Veeva RIM Basics on Veeva Basics Help

Set a Reference Leaf

Tue, 07 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

A reference leaf is a file that has already been submitted but needs to appear in the XML to indicate it is part of the current submission. You can use a previously-submitted and reviewed Submissions Archive document as a reference leaf, reducing the review time at the relevant Health Authority.

Coming from Full Vault?

Wed, 10 Dec 2025 00:00:00 +0000

For emerging biotech companies, establishing a robust and compliant Regulatory Information Management (RIM) system is a critical early step. While highly configurable enterprise systems offer extensive flexibility, they often require significant investment in time, resources, and personnel for implementation, validation, and maintenance. Veeva RIM Basics presents a streamlined, pre-configured alternative designed to meet the core needs of the industry with an accelerated path to value. This document outlines the key principles and functionalities of the RIM Basics platform. This document is designed for people new to the core Veeva Basics principals to help understand the key aspects of our approach.

RIM Basics: Document Viewer

Thu, 20 Nov 2025 00:00:00 +0000

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Having trouble viewing the course? Open it in a new tab.

Offboard a User

Wed, 01 Oct 2025 00:00:00 +0000

When a user leaves your organization, follow this checklist to ensure a smooth transition.

If the user leaving is a domain admin, they should make a different user a domain admin before they leave.
Login with delegate access to the user’s account before inactivating, and verify any active workflows and reassign to active user(s).
Filter the library by ‘Created By’ for the user to be inactivated, and as needed perform a bulk action to update the owner role to active user(s).
Ensure at least one other user has access to both Compliance Docs and Veeva Connect.

Prepare Resubmission

Tue, 16 Sep 2025 00:00:00 +0000

There may be a situation when your submission has been successfully transmitted via the electronic gateway (it has a Dossier Status of Transmission Successful), but you need to resend it back to the agency.

When this happens, you will need to prepare it for resubmission prior to resending it over the electronic gateway.

To prepare a submission for resubmission via the electronic gateway:

Navigate to Submission Mgmt > Submission Mgmt > Submissions.

Document Types, Subtypes, and Classifications

Fri, 22 Aug 2025 00:00:00 +0000

Document Type	Document Subtype	Classification
Clinical	Annual Report	General Investigational Plan
Clinical	Annual Report	Individual Study Information
Clinical	Annual Report	Status of Other Postmarketing Studies and Requirements
Clinical	Annual Report	Summary of Clinical Pharmacology Information
Clinical	Annual Report
Clinical	Case Report Forms
Clinical	Image Files
Clinical	Investigational Brochure (IB)	Appendices
Clinical	Investigational Brochure (IB)	Investigational Brochure (IB) Binder
Clinical	Investigational Brochure (IB)	Main Body
Clinical	Investigational Brochure (IB)	Published Report
Clinical	Investigational Brochure (IB)	Summary of Changes
Clinical	Investigational Brochure (IB)
Clinical	Listings	Abnormal Lab Values Patient Listing
Clinical	Listings	Adverse Events Listing
Clinical	Listings	Available on Request Listing
Clinical	Listings	Compliance and/or Drug Concentration Data Listing
Clinical	Listings	Demographic Data Listing
Clinical	Listings	Discontinued Patients Listing
Clinical	Listings	Individual Efficacy Response Data Listing
Clinical	Listings	Individual Laboratory Measurements Listing
Clinical	Listings	Patient Data Listing
Clinical	Listings	Patients Excluded from the Efficacy Analysis Listing
Clinical	Listings	Protocol Deviations Listing
Clinical	Listings
Clinical	Regulatory Support	Compliance with Screening Outcomes
Clinical	Regulatory Support	Declarations - Statements
Clinical	Regulatory Support	Financial and Other Arrangements
Clinical	Regulatory Support	Good Clinical Practice (GCP) Compliance
Clinical	Regulatory Support	Individual Patient Data - Statement of Availability
Clinical	Regulatory Support	Information About the Experts
Clinical	Regulatory Support	Information Amendment - Clinical
Clinical	Regulatory Support	Investigational Medicinal Product Dossier (IMPD) Clinical Data
Clinical	Regulatory Support	List of Studies Conducted with the same Investigational Medicinal Product (IMP)
Clinical	Regulatory Support	Modification Description
Clinical	Regulatory Support	Opinion of the Ethics Committee (EC)
Clinical	Regulatory Support	Overall Benefit-Risk Assessment
Clinical	Regulatory Support	Proof of Insurance
Clinical	Regulatory Support	Protocol Safety and Efficacy Template (PSEAT)
Clinical	Regulatory Support	Special Protocol Assessment Request - Clinical Study
Clinical	Regulatory Support
Clinical	Statistics and Data Management	Annotated CRF (aCRF)
Clinical	Statistics and Data Management	Annotated ECG Waveform Dataset
Clinical	Statistics and Data Management	Data Definition - Analysis Datasets ADaM
Clinical	Statistics and Data Management	Data Definition - Analysis Datasets Legacy
Clinical	Statistics and Data Management	Data Definition - Bioresearch Monitoring Program (BIMO)
Clinical	Statistics and Data Management	Data Definition - Data Tabulations Legacy
Clinical	Statistics and Data Management	Data Definition - Data Tabulations SDTM
Clinical	Statistics and Data Management	Data Definition - Miscellaneous
Clinical	Statistics and Data Management	Data Management Plan
Clinical	Statistics and Data Management	Data Monitoring Committee (DMC)
Clinical	Statistics and Data Management	Data Monitoring Plan
Clinical	Statistics and Data Management	Data on Bioequivalence Studies
Clinical	Statistics and Data Management	Dataset - Analysis ADaM
Clinical	Statistics and Data Management	Dataset - Analysis Legacy
Clinical	Statistics and Data Management	Dataset - Bioresearch Monitoring Program (BIMO)
Clinical	Statistics and Data Management	Dataset - Data Tabulation Legacy
Clinical	Statistics and Data Management	Dataset - Data Tabulation SDTM
Clinical	Statistics and Data Management	Dataset - Miscellaneous
Clinical	Statistics and Data Management	List of Patients Receiving Test Drug
Clinical	Statistics and Data Management	Program File - Analysis Datasets ADaM
Clinical	Statistics and Data Management	Program File - Analysis Datasets Legacy
Clinical	Statistics and Data Management	Randomization Scheme
Clinical	Statistics and Data Management	Reviewer’s Guide - Analysis Data (ADRG)
Clinical	Statistics and Data Management	Reviewer’s Guide - Bioresearch Monitoring Program (BIMO)
Clinical	Statistics and Data Management	Reviewer’s Guide - Study Data (CSDRG)
Clinical	Statistics and Data Management	Statistical Analysis Plan
Clinical	Statistics and Data Management	Statistical Output
Clinical	Statistics and Data Management	Subject Profile
Clinical	Statistics and Data Management
Clinical	Study Protocol	Full Protocol or Protocol Amendment
Clinical	Study Protocol	Protocol Synopsis
Clinical	Study Protocol	Study Design
Clinical	Study Protocol	Summary of Changes
Clinical	Study Protocol	Tracked Changes Version
Clinical	Study Protocol
Clinical	Study Report Appendices	Audit Certificates and Reports
Clinical	Study Report Appendices	Important Publications Referenced in the Report
Clinical	Study Report Appendices	Informed Consent Form (ICF)
Clinical	Study Report Appendices	Interlaboratory Standardization Methods
Clinical	Study Report Appendices	Investigator CVs
Clinical	Study Report Appendices	List and Description of Investigators and Sites
Clinical	Study Report Appendices	List of IECs and IRBs
Clinical	Study Report Appendices	Publications based on the study
Clinical	Study Report Appendices	Sample CRF
Clinical	Study Report Appendices	Signature Page
Clinical	Study Report Appendices	Statement of Investigator or 1572
Clinical	Study Report Appendices
Clinical	Study Reports	Documentation of Statistical Methods
Clinical	Study Reports	Legacy Clinical Study Report
Clinical	Study Reports	Microbiology Report
Clinical	Study Reports	Patient Narratives
Clinical	Study Reports	Postmarketing Description
Clinical	Study Reports	Published Study Report
Clinical	Study Reports	Report Body
Clinical	Study Reports	Study Report Binder
Clinical	Study Reports	Supporting Bioavailability/Pharmacokinetic (BA/PK) Report
Clinical	Study Reports	Synopsis
Clinical	Study Reports	Tables and Figures
Clinical	Study Reports	Title Page
Clinical	Study Reports
Clinical	Summaries	Clinical Overview
Clinical	Summaries	Comparative Bioavailability - Bioequivalence
Clinical	Summaries	Comprehensive Summary - Bioequivalence
Clinical	Summaries	Integrated Summary of Efficacy (ISE)
Clinical	Summaries	Integrated Summary of Immunogenicity
Clinical	Summaries	Integrated Summary of Safety (ISS)
Clinical	Summaries	List of References
Clinical	Summaries	Summary of Bioavailability or Bioequivalence Study
Clinical	Summaries	Summary of Biopharmaceutic Studies and Analytical Methods
Clinical	Summaries	Summary of Clinical Efficacy
Clinical	Summaries	Summary of Clinical Pharmacology Studies
Clinical	Summaries	Summary of Clinical Safety
Clinical	Summaries	Synopses of Individual Studies
Clinical	Summaries	Tabular Listing of All Clinical Studies
Clinical	Summaries
Clinical	Table of Contents
Clinical
IDMP	eAF FHIR Output
IDMP	EU IDMP Submission
IDMP
Labeling	Carton or Container Label
Labeling	Core Labeling	Company Core Data Sheet (CCDS)
Labeling	Core Labeling	Company Core Safety Information (CCSI)
Labeling	Core Labeling	Core Instructions for Use (IFU)
Labeling	Core Labeling	Core Patient Information
Labeling	Core Labeling	Target Product Label (TPL)
Labeling	Core Labeling
Labeling	Package Component - Mock-Ups and Specimens	Carton or Container Label - Mock-Up
Labeling	Package Component - Mock-Ups and Specimens	Patient Information - Mock-Up
Labeling	Package Component - Mock-Ups and Specimens	Prescribing Information - Mock-Up
Labeling	Package Component - Mock-Ups and Specimens	Specimen
Labeling	Package Component - Mock-Ups and Specimens
Labeling	Product Information	Consumer Medicine Information
Labeling	Product Information	Instructions for Use (IFU)
Labeling	Product Information	Medication Guide
Labeling	Product Information	Patient Information Leaflet (PIL)
Labeling	Product Information	Prescribing Information
Labeling	Product Information	Prescribing Information - Annotated
Labeling	Product Information	Product Information Combined
Labeling	Product Information	Product Information Combined - Annotated
Labeling	Product Information	Product Monograph
Labeling	Product Information	Structured Product Labeling (SPL)
Labeling	Product Information	Summary of Product Characteristics (SmPC)
Labeling	Product Information	Summary of Product Characteristics (SmPC) Comparison
Labeling	Product Information
Labeling	Supporting Labeling Documents	Braille
Labeling	Supporting Labeling Documents	Condition of the Authorisation - Annex II
Labeling	Supporting Labeling Documents	Label Comprehension Studies
Labeling	Supporting Labeling Documents	Labeling Decision Record (LDR)
Labeling	Supporting Labeling Documents	Labeling History
Labeling	Supporting Labeling Documents	Other Product Information
Labeling	Supporting Labeling Documents	Readability Testing Report
Labeling	Supporting Labeling Documents
Labeling
Literature
Nonclinical	Annual Report	Summary of Nonclinical Studies
Nonclinical	Annual Report
Nonclinical	Regulatory Support	Animal Rule
Nonclinical	Regulatory Support	Antibiotic Resistance Data
Nonclinical	Regulatory Support	Good Laboratory Practice (GLP) Compliance
Nonclinical	Regulatory Support	Information About the Experts
Nonclinical	Regulatory Support	Information Amendment - Nonclinical
Nonclinical	Regulatory Support	Investigational Medicinal Product Dossier (IMPD) Nonclinical Data
Nonclinical	Regulatory Support	List of Studies Conducted with the same Investigational Medicinal Product (IMP)
Nonclinical	Regulatory Support	Special Protocol Assessment Request - Carcinogenicity Study
Nonclinical	Regulatory Support
Nonclinical	Statistics and Data Management	Analysis ADAM Program
Nonclinical	Statistics and Data Management	Analysis Dataset
Nonclinical	Statistics and Data Management	Analysis Definition
Nonclinical	Statistics and Data Management	Analysis Legacy Data Definition
Nonclinical	Statistics and Data Management	Analysis Legacy Dataset
Nonclinical	Statistics and Data Management	Analysis Legacy Program
Nonclinical	Statistics and Data Management	Data Tabulation Data SEND Definition
Nonclinical	Statistics and Data Management	Legacy Data Tabulation Dataset
Nonclinical	Statistics and Data Management	Legacy Tabulation Definition - Nonclinical
Nonclinical	Statistics and Data Management	Miscellaneous Data Definition
Nonclinical	Statistics and Data Management	Miscellaneous Dataset
Nonclinical	Statistics and Data Management	Reviewer’s Guide - Study Data (NSDRG)
Nonclinical	Statistics and Data Management	SEND Data Tabulation Dataset
Nonclinical	Statistics and Data Management
Nonclinical	Study Protocol	Full Protocol or Protocol Amendment
Nonclinical	Study Protocol
Nonclinical	Study Reports	Appendices
Nonclinical	Study Reports	Audit Certificates Report
Nonclinical	Study Reports	Compliance and Drug Concentration Data
Nonclinical	Study Reports	Final Study Report
Nonclinical	Study Reports	Inter-Laboratory Standardisation Methods Quality Assurance
Nonclinical	Study Reports	Investigator Signatures
Nonclinical	Study Reports	Publications Based on Study
Nonclinical	Study Reports	Publications Referenced in Report
Nonclinical	Study Reports	Statistical Methods Interim Analysis Plan
Nonclinical	Study Reports	Study Report Binder
Nonclinical	Study Reports	Study Report Body
Nonclinical	Study Reports	Synopsis
Nonclinical	Study Reports	Tables, Figures, and Listings
Nonclinical	Study Reports
Nonclinical	Summaries	Introduction
Nonclinical	Summaries	Nonclinical Overview
Nonclinical	Summaries	Pharmacokinetic Tabulated Summary
Nonclinical	Summaries	Pharmacokinetic Written Summary
Nonclinical	Summaries	Pharmacology Tabulated Summary
Nonclinical	Summaries	Pharmacology Written Summary
Nonclinical	Summaries	Toxicology Tabulated Summary
Nonclinical	Summaries	Toxicology Written Summary
Nonclinical	Summaries
Nonclinical	Table of Contents
Nonclinical
Pharmacovigilance	Annual Report	Summary of Safety Information
Pharmacovigilance	Annual Report
Pharmacovigilance	Country Specific Periodic Reports / Line Listings	Line Listing
Pharmacovigilance	Country Specific Periodic Reports / Line Listings	Periodic Report
Pharmacovigilance	Country Specific Periodic Reports / Line Listings
Pharmacovigilance	Development Safety Update Report (DSUR)	Appendices
Pharmacovigilance	Development Safety Update Report (DSUR)	Line Listings of Serious Adverse Reactions
Pharmacovigilance	Development Safety Update Report (DSUR)	List of Subjects who Died During the Reporting Period
Pharmacovigilance	Development Safety Update Report (DSUR)	List of Subjects who Dropped Out of Studies During the Reporting Period
Pharmacovigilance	Development Safety Update Report (DSUR)	Published Report
Pharmacovigilance	Development Safety Update Report (DSUR)	Report Binder
Pharmacovigilance	Development Safety Update Report (DSUR)	Report Body
Pharmacovigilance	Development Safety Update Report (DSUR)	Summary
Pharmacovigilance	Development Safety Update Report (DSUR)	Title Page
Pharmacovigilance	Development Safety Update Report (DSUR)
Pharmacovigilance	Individual Case Safety Report	ICSR Cover Letter
Pharmacovigilance	Individual Case Safety Report	Report
Pharmacovigilance	Individual Case Safety Report
Pharmacovigilance	Periodic Adverse Experience Report (PAER / PADER)	Appendices
Pharmacovigilance	Periodic Adverse Experience Report (PAER / PADER)	Published Report
Pharmacovigilance	Periodic Adverse Experience Report (PAER / PADER)	Report Binder
Pharmacovigilance	Periodic Adverse Experience Report (PAER / PADER)	Report Body
Pharmacovigilance	Periodic Adverse Experience Report (PAER / PADER)
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Interval and Cumulative Summary Tabulations from Marketed Experience
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	List of the Sources of Information Used to Prepare the PBRER
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Listing of Interventional Studies with a Primary Objective of Post-Authorization Safety Monitoring
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Listing of Non-Interventional Studies with a Primary Objective of Post-Authorization Safety Monitoring
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Published Report
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Reference Information
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Report Binder
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Report Body
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Summary
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Tabular Summary of Safety Signals
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)	Title Page
Pharmacovigilance	Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR)
Pharmacovigilance	Regulatory Support	Good Pharmacovigilance Practice (GPP) Compliance
Pharmacovigilance	Regulatory Support	Information Related to the Qualified Person Responsible for Pharmacovigilance (QPPV)
Pharmacovigilance	Regulatory Support	Other Pharmacovigilance Information
Pharmacovigilance	Regulatory Support	Risk Communication
Pharmacovigilance	Regulatory Support
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)	Assessment Methodology
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)	Draft REMS
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)	Final Assessment Report
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)	Final REMS
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)	Modification History
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)	Related Documents
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)	Report Binder
Pharmacovigilance	Risk Evaluation and Mitigation Strategies (REMS)
Pharmacovigilance	Risk Management Plan	Additional Risk Minimization Measures (aRMM)
Pharmacovigilance	Risk Management Plan	Appendices
Pharmacovigilance	Risk Management Plan	Implementation Plan (for aRMMs)
Pharmacovigilance	Risk Management Plan	Post-Marketing Surveillance
Pharmacovigilance	Risk Management Plan	Published Report
Pharmacovigilance	Risk Management Plan	Related Documents
Pharmacovigilance	Risk Management Plan	Report Binder
Pharmacovigilance	Risk Management Plan
Pharmacovigilance	Safety Management Plan (SMP)	Safety Management Plan Protocol (SMP)
Pharmacovigilance	Safety Management Plan (SMP)
Pharmacovigilance	Table of Contents
Pharmacovigilance
Quality	Adventitious Agents Safety Evaluation
Quality	Annual Report	Summary of Manufacturing Changes
Quality	Annual Report	Summary of Microbiological Changes
Quality	Annual Report
Quality	Characterization of Drug Substance	Elucidation of Structure and Characteristics
Quality	Characterization of Drug Substance	Impurities
Quality	Characterization of Drug Substance
Quality	Comparability Protocols for Drug Product
Quality	Comparability Protocols for Drug Substance
Quality	Container Closure Systems for Drug Product
Quality	Container Closure Systems for Drug Substance
Quality	Control of Drug Product	Analytical Procedures
Quality	Control of Drug Product	Batch Analyses
Quality	Control of Drug Product	Characterization of Impurities
Quality	Control of Drug Product	Justification of Specifications
Quality	Control of Drug Product	Specifications
Quality	Control of Drug Product	Validation of Analytical Procedures
Quality	Control of Drug Product
Quality	Control of Drug Substance	Analytical Procedures
Quality	Control of Drug Substance	Batch Analyses
Quality	Control of Drug Substance	Justification of Specifications
Quality	Control of Drug Substance	Specifications
Quality	Control of Drug Substance	Validation of Analytical Procedures
Quality	Control of Drug Substance
Quality	Control of Excipients	Analytical Procedures
Quality	Control of Excipients	Certificate of Analysis (CoA)
Quality	Control of Excipients	Control of Excipients (Consolidated)
Quality	Control of Excipients	Excipients of Human or Animal Origin
Quality	Control of Excipients	Justification of Specifications
Quality	Control of Excipients	Novel Excipients
Quality	Control of Excipients	Specifications
Quality	Control of Excipients	Validation of Analytical Procedures
Quality	Control of Excipients
Quality	Description and Composition of the Drug Product
Quality	Drug Master Files for Drug Product
Quality	Drug Master Files for Drug Substance
Quality	Drug Product Stability	Post-Approval Stability Protocol and Stability Commitment
Quality	Drug Product Stability	Stability Data
Quality	Drug Product Stability	Stability Summary and Conclusions
Quality	Drug Product Stability
Quality	Drug Substance Stability	Post-Approval Stability Protocol and Stability Commitment
Quality	Drug Substance Stability	Stability Data
Quality	Drug Substance Stability	Stability Summary and Conclusions
Quality	Drug Substance Stability
Quality	Facilities and Equipment	Establishment Licensing
Quality	Facilities and Equipment	Facilities and Equipment Overview
Quality	Facilities and Equipment	Facilities Diagrams
Quality	Facilities and Equipment	Manufacturing Site Documents (MSD)
Quality	Facilities and Equipment
Quality	General Information about the Drug Substance	General Properties
Quality	General Information about the Drug Substance	Nomenclature
Quality	General Information about the Drug Substance	Structure
Quality	General Information about the Drug Substance
Quality	Manufacture of Drug Product	Batch Formula
Quality	Manufacture of Drug Product	Certificate of Analysis (CoA)
Quality	Manufacture of Drug Product	Controls of Critical Steps and Intermediates
Quality	Manufacture of Drug Product	Description of Manufacturing Process and Process Controls
Quality	Manufacture of Drug Product	Executed Production Record
Quality	Manufacture of Drug Product	Manufacturers
Quality	Manufacture of Drug Product	Process Validation and/or Evaluation
Quality	Manufacture of Drug Product
Quality	Manufacture of Drug Substance	Cell Bank Testing
Quality	Manufacture of Drug Substance	Cell Line Development
Quality	Manufacture of Drug Substance	Certificate of Analysis (CoA)
Quality	Manufacture of Drug Substance	Control of Materials
Quality	Manufacture of Drug Substance	Controls of Critical Steps and Intermediates
Quality	Manufacture of Drug Substance	Description of Manufacturing Process and Process Controls
Quality	Manufacture of Drug Substance	Executed Production Record
Quality	Manufacture of Drug Substance	Manufacturers
Quality	Manufacture of Drug Substance	Manufacturing Process Development
Quality	Manufacture of Drug Substance	Process Validation and/or Evaluation
Quality	Manufacture of Drug Substance
Quality	Pharmaceutical Development of the Drug Product	Compatibility
Quality	Pharmaceutical Development of the Drug Product	Components of Drug Product
Quality	Pharmaceutical Development of the Drug Product	Container Closure System
Quality	Pharmaceutical Development of the Drug Product	Drug Product
Quality	Pharmaceutical Development of the Drug Product	Manufacturing Process Development
Quality	Pharmaceutical Development of the Drug Product	Microbiological Attributes
Quality	Pharmaceutical Development of the Drug Product	Pharmaceutical Development of the Drug Product (Consolidated)
Quality	Pharmaceutical Development of the Drug Product
Quality	Quality Overall Summary	Appendices
Quality	Quality Overall Summary	Drug Product Summary
Quality	Quality Overall Summary	Drug Substance Summary
Quality	Quality Overall Summary	Introduction
Quality	Quality Overall Summary	Quality Overall Summary (Consolidated)
Quality	Quality Overall Summary	Regional Information Summary / Overview
Quality	Quality Overall Summary
Quality	Reference Standards or Materials for Drug Product
Quality	Reference Standards or Materials for Drug Substance
Quality	Regional Information	Alcohol Content Declaration
Quality	Regional Information	Assessment of Similarity
Quality	Regional Information	Batch Records (Master/Executed)
Quality	Regional Information	Certified Product Details
Quality	Regional Information	Comparability Protocols
Quality	Regional Information	Diluents and Coloring Agents in the Product Formula
Quality	Regional Information	Information on Batches used in Nonclinical and Clinical Studies
Quality	Regional Information	Lot Release
Quality	Regional Information	Materials of Animal and/or Human Origin
Quality	Regional Information	Medical Device
Quality	Regional Information	Method Validation Package
Quality	Regional Information	Multiple API Manufacturers
Quality	Regional Information	On Site Evaluation
Quality	Regional Information	Parent API Manufacturer with Various Sites
Quality	Regional Information	Pharmaceutical and Biological Availability
Quality	Regional Information	Porcine - Pork Declaration
Quality	Regional Information	Process Validation Scheme for the Drug Product
Quality	Regional Information	Regional Information (Consolidated)
Quality	Regional Information	Sample Information
Quality	Regional Information	Statistician’s Package
Quality	Regional Information	Supplier’s Compliance with Packaging and Colouring Standards
Quality	Regional Information	Yearly Biologic Product Report (YBPR)
Quality	Regional Information
Quality	Regulatory Support	Annexes - Manufacturing
Quality	Regulatory Support	API Change Control
Quality	Regulatory Support	Certificate - Ph. Eur. Suitability (CEP)
Quality	Regulatory Support	Certificate - Pharmaceutical Product (CPP)
Quality	Regulatory Support	Certificate - Plasma Master File (PMF)
Quality	Regulatory Support	Certificate - Vaccine Antigen Master File (VAMF)
Quality	Regulatory Support	Comparison of Generic Drug and Reference Listed Drug
Quality	Regulatory Support	Data Verification
Quality	Regulatory Support	DMF - ASMF Authorization - Reference Letter
Quality	Regulatory Support	Environmental Risk Assessment
Quality	Regulatory Support	Flow-Chart of Manufacturing Process
Quality	Regulatory Support	Genetically Modified Organism (GMO) Assessment
Quality	Regulatory Support	Good Manufacturing Practice (GMP) Compliance
Quality	Regulatory Support	Import and Export Information
Quality	Regulatory Support	Information About the Experts
Quality	Regulatory Support	Information Amendment - Quality
Quality	Regulatory Support	Investigational Medicinal Product Dossier (IMPD) Quality Consolidated
Quality	Regulatory Support	Investigational Medicinal Product Dossier (IMPD) Summary of Changes
Quality	Regulatory Support	Investigational Medicinal Product Dossier (IMPD) Tracked Changes
Quality	Regulatory Support	Manufacturer Qualification Documents
Quality	Regulatory Support	Manufacturing Authorization
Quality	Regulatory Support	Non-Investigational Medicinal Products Used in Trial
Quality	Regulatory Support	Pharmacy Manual
Quality	Regulatory Support	Qualified Person (QP) Declaration
Quality	Regulatory Support	Special Protocol Assessment Request - Stability Study
Quality	Regulatory Support	Statement - Non-Animal Sourced Materials
Quality	Regulatory Support	Statement - Right of Reference
Quality	Regulatory Support
Quality	Solvents for Reconstitution and Diluents
Quality	Table of Contents
Quality
Regulatory	Accelerated and Priority Review	Correspondence Regarding Accelerated and Priority Review
Regulatory	Accelerated and Priority Review	Emergency Use Authorization (EUA) Information
Regulatory	Accelerated and Priority Review	Fast Track Status Decision
Regulatory	Accelerated and Priority Review	Other Application for Accelerated Review Designation
Regulatory	Accelerated and Priority Review	Request - Breakthrough Therapy Designation
Regulatory	Accelerated and Priority Review	Request - Fast Track Designation
Regulatory	Accelerated and Priority Review	Request - Priority Review
Regulatory	Accelerated and Priority Review	Request - Rolling Review
Regulatory	Accelerated and Priority Review	Tropical Disease Priority Review Voucher
Regulatory	Accelerated and Priority Review	Withdrawal Request - Fast Track Designation
Regulatory	Accelerated and Priority Review
Regulatory	Administrative Information	Additional Data - Information
Regulatory	Administrative Information	Annexes - Other
Regulatory	Administrative Information	Approval Application (Copy)
Regulatory	Administrative Information	ATC Product Code Submission
Regulatory	Administrative Information	Background of Origin - Discovery of Development
Regulatory	Administrative Information	Checklist Form - Self Assessment Report
Regulatory	Administrative Information	Comparison Table
Regulatory	Administrative Information	Compassionate Use
Regulatory	Administrative Information	Confirmation of Contract
Regulatory	Administrative Information	Cover Letter
Regulatory	Administrative Information	Cross Reference to Previously Submitted Information
Regulatory	Administrative Information	Dispute Resolution Information
Regulatory	Administrative Information	Field Alert Reports
Regulatory	Administrative Information	General Note to Reviewer
Regulatory	Administrative Information	Information on Development Studies
Regulatory	Administrative Information	Justification for Not Providing Biopharmaceutic Studies
Regulatory	Administrative Information	Labeling Exemption
Regulatory	Administrative Information	Lifecycle Management Tracking Table
Regulatory	Administrative Information	List of Attached Documents
Regulatory	Administrative Information	List of Authorized to Persons to Incorporate by Reference
Regulatory	Administrative Information	List of Similar Products
Regulatory	Administrative Information	Other Administrative Information
Regulatory	Administrative Information	Other Documents on Previously Approved Drugs
Regulatory	Administrative Information	Power of Attorney
Regulatory	Administrative Information	Pricing Information
Regulatory	Administrative Information	Proof of Delivery
Regulatory	Administrative Information	Registration Status
Regulatory	Administrative Information	Request for Waiver - In Vivo Bioavailability Studies
Regulatory	Administrative Information	Request for Waiver - In Vivo Studies
Regulatory	Administrative Information	Request for Waiver - Other
Regulatory	Administrative Information	Table of Contents
Regulatory	Administrative Information	Template of Database Entering
Regulatory	Administrative Information
Regulatory	Annual Report	Distribution Data
Regulatory	Annual Report	Foreign Marketing
Regulatory	Annual Report	IND or NDA Annual Report (Consolidated)
Regulatory	Annual Report	Log of Outstanding Regulatory Business
Regulatory	Annual Report	Status of Postmarketing Study Commitments and Requirements
Regulatory	Annual Report	Summary of Labeling Changes
Regulatory	Annual Report	Summary of Other Significant New Information
Regulatory	Annual Report
Regulatory	Application Forms	Form - Application
Regulatory	Application Forms	Form - Application Annex
Regulatory	Application Forms	Form - Certification and Attestation
Regulatory	Application Forms	Form - Declaration Radiopharmaceuticals
Regulatory	Application Forms	Form - Drug Master File (DMF)
Regulatory	Application Forms	Form - EudraCT
Regulatory	Application Forms	Form - Fee
Regulatory	Application Forms	Form - Full Declaration
Regulatory	Application Forms	Form - Manufacturer Information
Regulatory	Application Forms	Form - Other
Regulatory	Application Forms	Form - Periodic Report - PSUR - PBRER
Regulatory	Application Forms	Form - Pharmaceutical Information for Parenteral Preparations
Regulatory	Application Forms	Form - Renewal
Regulatory	Application Forms	Form - Specimen Submission
Regulatory	Application Forms	Form - Status Marketing Authorisations Abroad
Regulatory	Application Forms	Form - Variation
Regulatory	Application Forms	Form 1571
Regulatory	Application Forms	Form 2252
Regulatory	Application Forms	Form 2253
Regulatory	Application Forms	Form 2567
Regulatory	Application Forms	Form 3397
Regulatory	Application Forms	Form 356h
Regulatory	Application Forms	Form 3674
Regulatory	Application Forms	Form 3792
Regulatory	Application Forms	Form 3794
Regulatory	Application Forms	Form 3938
Regulatory	Application Forms	Form 3988
Regulatory	Application Forms	Proof of Payment
Regulatory	Application Forms	Regulatory Enrolment (REP) - Company Template (CO)
Regulatory	Application Forms	Regulatory Enrolment (REP) - Product Information Template (PI)
Regulatory	Application Forms	Regulatory Enrolment (REP) - Regulatory Transaction Template (RT)
Regulatory	Application Forms	Signature Page
Regulatory	Application Forms
Regulatory	Application Status	Request - Inactivation
Regulatory	Application Status	Request - Reactivation
Regulatory	Application Status	Request - Reconsideration Documentation
Regulatory	Application Status	Request - Reinstatement
Regulatory	Application Status	Withdrawal Request - Investigational Application
Regulatory	Application Status	Withdrawal Request - Listed Drug (Generic)
Regulatory	Application Status	Withdrawal Request - Marketed Product
Regulatory	Application Status	Withdrawal Request - Other
Regulatory	Application Status	Withdrawal Request - Unapproved Marketing Application
Regulatory	Application Status
Regulatory	Authorizations - Declarations - Statements	Authorisation - EU-EFTA
Regulatory	Authorizations - Declarations - Statements	Authorization - Letter
Regulatory	Authorizations - Declarations - Statements	Authorization - Sharing Information
Regulatory	Authorizations - Declarations - Statements	Declaration - Applicant
Regulatory	Authorizations - Declarations - Statements	Declaration - Authenticity
Regulatory	Authorizations - Declarations - Statements	Declaration - Co-Marketed Medicines
Regulatory	Authorizations - Declarations - Statements	Declaration - Electronic Copy
Regulatory	Authorizations - Declarations - Statements	Statement - Basis for Submission
Regulatory	Authorizations - Declarations - Statements	Statement - Generic Drug Enforcement Act
Regulatory	Authorizations - Declarations - Statements	Statement - Other
Regulatory	Authorizations - Declarations - Statements
Regulatory	Certificates and Certifications	Certificate - Legal Registration
Regulatory	Certificates and Certifications	Certificate - Medical Device Approval
Regulatory	Certificates and Certifications	Certificate - Other
Regulatory	Certificates and Certifications	Certification - Applicant - MAH
Regulatory	Certificates and Certifications	Certification - Approvals
Regulatory	Certificates and Certifications	Certification - Commissioned Research
Regulatory	Certificates and Certifications	Certification - Debarment
Regulatory	Certificates and Certifications	Certification - Drug Quality and Safety
Regulatory	Certificates and Certifications	Certification - Enterprises
Regulatory	Certificates and Certifications	Certification - Field Copy
Regulatory	Certificates and Certifications	Certification - Financial Certification and Disclosure Information
Regulatory	Certificates and Certifications	Certification - Lawful Source
Regulatory	Certificates and Certifications	Certification - Other
Regulatory	Certificates and Certifications	Certification - Qualification
Regulatory	Certificates and Certifications	Certification - Registrar of Companies
Regulatory	Certificates and Certifications	Certification - Registration
Regulatory	Certificates and Certifications	Certification - South African Pharmacy Council (SAPC) Registration
Regulatory	Certificates and Certifications
Regulatory	Clinical Trial Information	Certifications of Clinical Trials
Regulatory	Clinical Trial Information	Declaration of the End of Trial Form
Regulatory	Clinical Trial Information	Diversity Plan
Regulatory	Clinical Trial Information	EudraCT Number Confirmation
Regulatory	Clinical Trial Information	Form - Clinical Trial Site Information
Regulatory	Clinical Trial Information	Information on Prior-Related Clinical Applications
Regulatory	Clinical Trial Information	Information Related to Clinical Trials
Regulatory	Clinical Trial Information	Investigational Carton and Container Labels
Regulatory	Clinical Trial Information	Investigational Labeling
Regulatory	Clinical Trial Information	Lay Summary
Regulatory	Clinical Trial Information	Notice of Compliance (NOC) with Conditions
Regulatory	Clinical Trial Information	Notification of Discontinuation of Clinical Trial
Regulatory	Clinical Trial Information	Potential Safety Risk
Regulatory	Clinical Trial Information	Reference Product Label
Regulatory	Clinical Trial Information	Request to Charge for Clinical Trial
Regulatory	Clinical Trial Information	Request to Charge for Expanded Access
Regulatory	Clinical Trial Information
Regulatory	Contact - Sponsor - Applicant Information	Change in Contact - Agent
Regulatory	Contact - Sponsor - Applicant Information	Change of Address
Regulatory	Contact - Sponsor - Applicant Information	Change of Ownership
Regulatory	Contact - Sponsor - Applicant Information	Change of Sponsor - MAH
Regulatory	Contact - Sponsor - Applicant Information	Proposed Holder of Certificate of Registration (PHCR)
Regulatory	Contact - Sponsor - Applicant Information	Transfer of Obligation
Regulatory	Contact - Sponsor - Applicant Information
Regulatory	Correspondence	Acknowledgement of Receipt
Regulatory	Correspondence	Agency Decisions
Regulatory	Correspondence	Approval Letter
Regulatory	Correspondence	From Health Authority
Regulatory	Correspondence	Health Authority Advice
Regulatory	Correspondence	Meeting Correspondence
Regulatory	Correspondence	Meeting Granted Letter
Regulatory	Correspondence	Other Correspondence
Regulatory	Correspondence	Record of Contact
Regulatory	Correspondence	Request for Information
Regulatory	Correspondence	To Health Authority
Regulatory	Correspondence
Regulatory	Data Submission	IDMP FHIR Message
Regulatory	Data Submission
Regulatory	Emergency Care Research	Correspondence Regarding Emergency Care Research
Regulatory	Emergency Care Research	Exemption from Informed Consent for Emergency Care Research
Regulatory	Emergency Care Research	Public Disclosure Statement for Emergency Care Research
Regulatory	Emergency Care Research
Regulatory	Foreign Regulatory Information	Data Similarities and Differences
Regulatory	Foreign Regulatory Information	Documents on Usage Status Abroad
Regulatory	Foreign Regulatory Information	Foreign Evaluation Reports
Regulatory	Foreign Regulatory Information	Foreign Regulatory Status
Regulatory	Foreign Regulatory Information	International Information
Regulatory	Foreign Regulatory Information
Regulatory	Health Authority Interactions	Commitments Master List
Regulatory	Health Authority Interactions	Health Authority Questions Master List
Regulatory	Health Authority Interactions
Regulatory	Investigational Medicinal Product Dossier (IMPD) Published
Regulatory	Meeting Materials and Pre-Submission Details	Background Materials
Regulatory	Meeting Materials and Pre-Submission Details	Compliance with Meeting and Pre-Submission Processes
Regulatory	Meeting Materials and Pre-Submission Details	Compliance with Pre-Submission Planning Form and Letter
Regulatory	Meeting Materials and Pre-Submission Details	Details of Additional Data to be Submitted
Regulatory	Meeting Materials and Pre-Submission Details	Meeting Request
Regulatory	Meeting Materials and Pre-Submission Details	Pre-Submission Details
Regulatory	Meeting Materials and Pre-Submission Details	Sponsor Meeting Minutes
Regulatory	Meeting Materials and Pre-Submission Details
Regulatory	Multidisciplinary Information	Information Amendment - Multiple Module
Regulatory	Multidisciplinary Information	Multidisciplinary Tabular Summaries
Regulatory	Multidisciplinary Information
Regulatory	Orphan Drug Information	Form - Application for Recognition of Orphan Drug Status
Regulatory	Orphan Drug Information	Orphan Drug Designation
Regulatory	Orphan Drug Information	Orphan Drug Status - Decision
Regulatory	Orphan Drug Information	Orphan Market Exclusivity
Regulatory	Orphan Drug Information	Orphan Market Exclusivity - Similarity
Regulatory	Orphan Drug Information
Regulatory	Patent and Exclusivity Information	Data Protection Information
Regulatory	Patent and Exclusivity Information	Exclusivity Claim
Regulatory	Patent and Exclusivity Information	Extended Data - Market Exclusivity
Regulatory	Patent and Exclusivity Information	Patent Information and Certification
Regulatory	Patent and Exclusivity Information
Regulatory	Pediatric (Paediatric) Information	Correspondence Regarding Pediatric Exclusivity or Study Plans
Regulatory	Pediatric (Paediatric) Information	Information Related to Pediatrics (Paediatrics)
Regulatory	Pediatric (Paediatric) Information	Paediatric Investigation Plan (PIP) - Pediatric Study Plan (PSP)
Regulatory	Pediatric (Paediatric) Information	Request - Deferral of Pediatric Studies
Regulatory	Pediatric (Paediatric) Information	Request - Pediatric Exclusivity Determination
Regulatory	Pediatric (Paediatric) Information	Request - Proposed Pediatric Study and Amendments
Regulatory	Pediatric (Paediatric) Information	Request - Waiver of Pediatric Studies
Regulatory	Pediatric (Paediatric) Information
Regulatory	Post-Authorization Information	Other Post-Approval Information
Regulatory	Post-Authorization Information	Post-Approval CMC Changes
Regulatory	Post-Authorization Information	Post-Approval Labeling Changes
Regulatory	Post-Authorization Information	Post-Marketing Studies
Regulatory	Post-Authorization Information
Regulatory	Product Name Information	Documents about Japanese Accepted Names for Pharmaceuticals
Regulatory	Product Name Information	Look-alike/Sound-alike Assessment
Regulatory	Product Name Information	Nomenclature Certification of Product Common Name
Regulatory	Product Name Information	Nonproprietary Name Information (INN)
Regulatory	Product Name Information	Proprietary Name Information
Regulatory	Product Name Information	Trade Name Declaration
Regulatory	Product Name Information	Trademark Information
Regulatory	Product Name Information
Regulatory	Promotional Materials	Annotated Label
Regulatory	Promotional Materials	Annotated Material
Regulatory	Promotional Materials	Annotated Reference
Regulatory	Promotional Materials	Clean Material
Regulatory	Promotional Materials	Pre-dissemination Review of Television Ads
Regulatory	Promotional Materials	Presubmission Accelerated Launch Materials
Regulatory	Promotional Materials	Presubmission Accelerated Non-Launch Materials
Regulatory	Promotional Materials	Promotional 2253 Materials
Regulatory	Promotional Materials	Request for Advisory Comments on Launch Materials
Regulatory	Promotional Materials	Request for Advisory Comments on Non-Launch Materials
Regulatory	Promotional Materials
Regulatory	Request for Comments and Advice	Request for Comments and Advice - Other
Regulatory	Request for Comments and Advice	Request for Scientific Advice
Regulatory	Request for Comments and Advice
Regulatory	Response to Questions and Request for Information	Response to Questions (RTQ)
Regulatory	Response to Questions and Request for Information	Response to Request for Information (RFI)
Regulatory	Response to Questions and Request for Information
Regulatory	Specific Requirements for Different Types of Applications	Combination Medicine Consent
Regulatory	Specific Requirements for Different Types of Applications	Conditional Marketing Authorisation
Regulatory	Specific Requirements for Different Types of Applications	Exceptional Circumstances
Regulatory	Specific Requirements for Different Types of Applications	Information for Bibliographical (Literature) Based Applications
Regulatory	Specific Requirements for Different Types of Applications	Information for Generic - Hybrid - Bio-Similar Applications
Regulatory	Specific Requirements for Different Types of Applications	Medicines Register Details
Regulatory	Specific Requirements for Different Types of Applications	OTC Product Assurances
Regulatory	Specific Requirements for Different Types of Applications	Summaries of Designated Reviews on Poisonous - Deleterious Drugs
Regulatory	Specific Requirements for Different Types of Applications	Umbrella Brand Assessment
Regulatory	Specific Requirements for Different Types of Applications
Regulatory	Summary Introduction
Regulatory	Translation Acknowledgements or Certificates
Regulatory
Staged
Submission Ready	Clinical Study
Submission Ready	Nonclinical Study
Submission Ready	Report
Submission Ready
Submissions
Submissions Archive	Content
Submissions Archive	Structure
Submissions Archive
Templates
UDI	UDI Submission
UDI
Unclassified

EMA eSub Account Request

Thu, 21 Aug 2025 00:00:00 +0000

This document is intended to be used as a checklist to guide customers in the setup of the EMA eSubmissions Gateway Connection for Veeva RIM Publishing. It is meant to be used in conjunction with the following EMA information:

Prerequisites

Access to the following website: https://esubregistration.ema.europa.eu/registration/
Existing personal certificate

Procedure

Open the EMA’s eSubmission Registration.
Complete Step 1 of eSubmission Registration. Customer must fill in all fields and click Next.

EMA eSub Publishing Gateway Setup

Thu, 21 Aug 2025 00:00:00 +0000

EMA Guidance

Note Always refer to the EMA references prior to proceeding to ensure the latest guidance

Sequence of Steps

Some of the steps in the sections below may be executed concurrently. This is indicated by the Prerequisites for each section. Otherwise, the sections are in the order in which they should be executed.

FDA ESG AS2 Account Request

Thu, 21 Aug 2025 00:00:00 +0000

Prerequisites

Review Setting up an AS2 Account Checklist
Review with your IT Department:

Verify that the whitelisting settings are configured
- Modify AS2 endpoint to deliver test submissions:
  - URL: https://upload-api-esgng.fda.gov:4080/as2/receive/test
  - To allow connections to (sending) IP 15.205.247.22 and 3.31.183.245 over port 4080
  - To allow connections from (receiving) IP 150.148.0.0/16 over port 4080

Procedure

Open the FDA page: Setting up an AS2 Account Checklist.
Create/Locate your Letter of Non-Repudiation Agreement.
- You must prepare this letter

FDA ESG Help Desk Portal

Thu, 21 Aug 2025 00:00:00 +0000

Clear communication with the FDA ESG Help Desk is vital for timely provisioning of the Sandbox and Production gateway connections. Their portal is available at https://esghelpdesk.fda.gov/helpdesk and it may be used to communicate with the ESG Help Desk. You may create an account through their website by clicking on the “Forgot Password” link.

Account Deactivation

All FDA ESG NextGen accounts that do not have any activity for 60 days will be deactivated. To avoid deactivation, a test submission can be sent to center GWTEST with a submission type of ConnectTest, or you can use the “Forgot Password” link to reset your password within the 60 day window.

FDA ESG Publishing Gateway Common Issues & Troubleshooting

Thu, 21 Aug 2025 00:00:00 +0000

This page addresses any/all known issues and potential resolutions. If you are unable to resolve your issue after reviewing this page, contact support.

Issue: Blank MDN (Acknowledgement)

Transmission is successful but only 1 acknowledgement is sent back and it is blank.

Potential Resolution: Verify Sponsor and Health Authority ID aren’t mismatched. Be sure the Sponsor or Health Authority ID in Veeva RIM is identical to that of the FDA. For example, if your Sponsor ID (DUNS number) is: 12-345-6789 be sure it is that way in the gateway profile and that way on the FDA side. If you have Sponsor ID as 123456789 and the agency has it as 12-345-6789 it could cause this issue to occur.

FDA ESG Publishing Gateway Setup

Thu, 21 Aug 2025 00:00:00 +0000

This page explains how to set up the FDA ESG NextGen UAT Gateway Connection for Veeva RIM Publishing. It is meant to be used in conjunction with the following FDA information:

FDA Guidance

Note: Always refer to the FDA references prior to proceeding to ensure the latest guidance.

Preparation

The following information must be collected, as it will be provided to the FDA and into Veeva RIM for each configured environment.

Finalize Test Gateway Profile Configuration

Thu, 21 Aug 2025 00:00:00 +0000

Prerequisites

You must have received an account activation email from the FDA after completing registration steps in Vault User Account Setup/Configuration.

The FDA must have provided you with the following:

.P7B Certificate
Health Authority ID ZZFDATST
Healthy Authority URL https://upload-api-esgng.fda.gov:4080/as2/receive/test

Procedure

Note this information below must be provided to Veeva to perform on your behalf. You can submit a ticket to GSC with the certificates and the needed details below.

Access the US FDA Async ESG Gateway Profile.

Gateway Profile Setup

Thu, 21 Aug 2025 00:00:00 +0000

Prerequisites

Gateway account activation confirmation from EMA eSub Account Request, step 5.

Procedure

Note This information below must be provided to Veeva to perform on your behalf. You can submit a ticket to GSC with the certificates and the needed details below.

Import/Export a Certificate

Thu, 21 Aug 2025 00:00:00 +0000

Import a Certificate

Ensure you mark the Key as Exportable when Importing into System.
Ensure the user saves the password somewhere they will be able to locate it.

Export a Certificate

The FDA provides instructions for exporting certificates.

The steps provided by the FDA have not been updated for Edge (they are still based upon Internet Explorer). The following are updated for using the EDGE Browser.

Public Key

From the EDGE browser top right corner (…), go to Settings.

Load Testing

Thu, 21 Aug 2025 00:00:00 +0000

Per NextGen ESG AS2 Setup Instructions only a single Test Submission needed for UAT.

Prerequisites

You will need to determine what type of Load Test is required, based on the AS2 guidance below (from: Electronic Submissions Gateway (ESG) Load Test)

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) requires the following Load Test submission sizes based on the type of submissions you plan to send to the Gateway:

If you plan to send large files (1GB or more), please submit a 2 GB single file submission

Prepare Test Submissions

Thu, 21 Aug 2025 00:00:00 +0000

Prerequisites

All previous steps are completed.
Access to the following website: https://esubweb.ema.europa.eu/esubmission-ui/#/ (delivery file generator)

Procedure

Create a new test Marketing Application as follows:
- Application Name: EU-TEST-[Your Company Name]
- Lead Market: European Union
- Region: European Union
- Application Type: Marketing Authorisation Application (MAA)
- Procedure Type: Centralised Procedure
- Primary Product Family: as applicable
- Application Folder Name: leave blank (will be generated upon save)
- Applicant: as applicable
- Primary Health Authority: European Medicines Agency
- Application UUID: leave blank (will be generated upon save)
- Dossier Format: eCTD
- XML Regional DTD / XSD Version: EU 3.0.1
- XML ICH DTD / XSD Version: ICH 3.2
- Validation Criteria Version: EU 7.1
- Create Node Extension: Yes
- Content Plan Template: CTD Content Plan Template
Create and publish a new submission 0000 as follows:

Prepare Test Submissions

Thu, 21 Aug 2025 00:00:00 +0000

Review Section 5 of the ESG NextGen Unified Submission Portal Guide for Industry Users to determine test submission approach.

Prerequisites

Create an Organization record in Veeva RIM with:

DUNS number
An Organization Type of Registration Holder
This can be done by going to an Application Record (Submission Mgmt Tab Collection > Submission Mgmt > Application)
- Setting the Publish in Vault? field to Yes
- Going to the Publishing Details Section
- Clicking in the field for Applicant, and selecting +Organization

Create the following two Contact and Submission Contact records (be sure to include Contact Type, email, phone number type, phone number).

Production Gateway Profile Setup

Thu, 21 Aug 2025 00:00:00 +0000

Prerequisites

Previous steps successfully completed.

Procedure

Note This information below must be provided to Veeva to perform on your behalf. You can submit a ticket to GSC with the certificates and the needed details below.

Login to the Production Vault and navigate to ADMIN section > Settings > Gateway Profiles > eu_ema_esub_v and click Edit.
Details section

Register Test Account

Thu, 21 Aug 2025 00:00:00 +0000

Prerequisites

Complete the AS2 Account Request procedure
Obtain a Digital Certificate
Acquire the Vault FDA ESG Test User Login information and Vault AS2 URL (as outlined in (FDA ESG AS2 Account Request)

Procedure

Register for an ESG NextGen account.
- Refer to Step 2 of the AS2 Account Set-Up, you will need to send an email to the FDA providing the information listed below.
Download and complete the AS2 ESG NextGen Gateway Configuration Information.docx form.

You will need to provide the following information to provide in the form:

Set Up Production Gateway

Thu, 21 Aug 2025 00:00:00 +0000

Prerequisites

Complete all preceding Test Gateway steps for the Sandbox environment
Receive email from the FDA indicating that you are approved for a Production Account
The Veeva Publishing application is active in your Production Vault.

The FDA must have provided you with the following:

.P7B Certificate for Production
Health Authority ID ZZFDA
Healthy Authority URL https://upload-api-esgng.fda.gov:4080/as2/receive

Procedure

Production FOLLOW-UP

Next steps:
- Wait for instructions from the FDA regarding the Production account.
Create FDA ESG User / Security setup in Production. Follow Steps listed in Section 2.3.1.

Vault User Account Setup/Configuration

Thu, 21 Aug 2025 00:00:00 +0000

Procedure

Determine if a No Expiration Security Policy already exists (if not, one will need to be created).
- If there isn’t already a Security Policy available that allows for no password expiration, you will need to create a new one
  (Note: you must be a Domain Admin to create a Security Policy).
- If this step is not completed, the ESG connection will fail when the password expires in accordance with your existing password policy.

Create & Share a Content Plan View

Tue, 19 Aug 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

You can edit the columns that display in your content plan and save it as a view to make it easy to view your content plan details. You can also share that view with other users.

Create a Content Plan View

To create a content plan view:

Continuous Publishing

Mon, 18 Aug 2025 00:00:00 +0000

Publishing with Veeva RIM Basics is as easy as one two three!

Your documents need to be in a steady state.
Your content plan needs to be ready for use.
You need to turn on continuous publishing.

The decision of when to turn on continuous publishing is up to you but Veeva recommends you turn it on as early as is reasonable. For example, you’ve been authoring and matching documents, added hyperlinks, modified bookmarks on your renditions, and you’re starting to wonder what your submission is looking like at this point.

RIM Basics Users

Fri, 25 Jul 2025 00:00:00 +0000

Vault Admins are responsible for creating and managing users in Veeva Basics. You can perform all of the user administration functionality from the RIM Admin > Users tab.

User Types

Vault users are categorized into three (3) different user types:

Domain Users: Users from your company’s domain, such as your peer employees. This is the most common type for new users.
Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company’s vault.
VeevaID Users: Users that are not employees of your company and do not have their own Vault User ID. Vault Admins can register a VeevaID user to their Vault and then send the user an automated email prompting them to finish the registration process.

Security Profiles & Application Licenses

You can provide users access to Vault based on their role at your organization using security profiles and licenses.

Applications

Tue, 15 Jul 2025 00:00:00 +0000

Applications allow you to organize your data and documents across multiple submissions. Applications are used to create submissions, which are then used to create submission content plans.

Applications in Veeva RIM Basics can contain multiple submissions. The application represents a set of documents that seek approval from a specific regulatory authority to market and sell a product in certain locations. The submission is an instance of that set of documentation sent to a regulatory authority. Over the life of a product, multiple submissions will be made from the associated application.

Dashboards

Fri, 11 Jul 2025 00:00:00 +0000

Dashboards can be accessed by navigating to Reports and Dashboards > Dashboards in the Submission Mgmt tab collection.

The following dashboards are available to help you monitor document metrics and track the status of your content plans:

Name	Description
Content Plan Status Dashboard	This dashboard displays important status information for a content plan, including matched document status by module, overall content plan status by module, how many content plan items have multiple matched documents, and how many content plan items do not have any matched documents.
Document Metrics Dashboard	This dashboard displays important metrics for your documents, including how many workflows are in progress, how many tasks are available, unassigned, and overdue, how many documents have been created in the last week, the average number of days from document creation to approval, and more.

To view a dashboard:

Document Lifecycle

Fri, 11 Jul 2025 00:00:00 +0000

Reports

Fri, 11 Jul 2025 00:00:00 +0000

Reports can be accessed by navigating to Reports and Dashboards > Reports in the Submission Mgmt tab collection.

Note Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form.

The following reports are available in Veeva RIM Basics:

Activate Items in a Content Plan & Make it Ready for Use

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Content Plans allow you to define each document and file that will be submitted to the Health Authority. The Submission Content Plan is a hierarchical structure that represents the list of all documents expected as part of a submission. Your team will match documents to the items activated in your content plan.

Add a Correspondence with Health Authority

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

You can upload and manage correspondence with health authorities and other organizations in two ways. You can forward email conversations and attachments straight to your Document Inbox or you can manually add correspondence documents by uploading them directly to the Library.

Add a Document Relationship to a Document

Wed, 09 Jul 2025 00:00:00 +0000

Document relationships create a connection between two documents. Unlike document link annotations, relationships do not have a specific location in either the source document or the targeted document.

Relationships may or may not be specific to a single version of the source or target document.

Relationship Types available in Veeva RIM Basics

Based on: Points to the document and version when the Make a Copy action was used
Linked Documents: Allows you to relate to a specific version of a specific document

Add or Modify XML fields in an Application

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

XML fields are used in regulatory submissions to help define the structure and metadata of the submission.

In RIM Basics: Submissions, most XML fields are automatically populated in an application - which is then pushed to the submission via the Submission Wizard - based on the equivalent field in the relevant application relationship: Products, Active Substances, Inactive Ingredients, Therapeutic Indications, Clinical Studies, and Nonclinical Studies.

Add or Remove a Document from a Content Plan

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

To complete your content plan, you must add documents to the active content plan items. If the documents you want to add already exist in Vault, use Match Document Mode to find and match the existing documents to the content plan items. If the documents do not yet exist in Vault, add the new documents directly to the content plan items.

Application Chronology Report

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

The Application Chronology Report helps you track Application Submissions, Regulatory Objectives, Commitments, and Correspondences in chronological order. It gives you a timeline view of your application all in one place.

The date that displays on the report is specific to the type of record.

Archive a Submission

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Complete the following steps to archive a submission after importing it to the Submissions Archive:

In the Submission Mgmt > Submissions tab, open the submission you imported to the Submissions Archive and click Edit.
Enter the Actual Submission Date for when the submission was sent to the Health Authority.
Click Save to save the changes.
From the Workflow Actions menu, select Change State to Archived.
In the confirmation dialog, click Yes to confirm that you want to change the submission’s status to Archived.

Viewing Archived Submissions

Complete the following steps to view an archived submission:

Assign a Submissions Publishing License to a User

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin

To assign a Submission Publishing license to a user:

In RIM Admin > Users, click the Actions menu ().
Select Edit Columns, as the Submissions Publishing column needs to be added.
Select RIM: Submissions Publishing in the Available Columns list.

Change a Document's State to Approved

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

If a document does not require an eSignature for approval, you can manually approve it.

Complete the following steps to manually approve a document:

From the Submission Mgmt > Library tab, open the document you want to approve.
From the Workflow Actions menu, select Change State to Approved. Vault displays a dialog asking you to confirm that you want to change the document to Approved.
Click Yes. Vault updates the document status to Approved.

Content Plans

Wed, 09 Jul 2025 00:00:00 +0000

Submission content plans help you collect the documents that you want to include in a single submission package. Content plans allow you to quickly assess which documents have been included and which documents are missing, and allow you to verify each document’s approval status to see if they are ready to be submitted.

After you’ve created an application and submission, you can use the submission to create a submission content plan.

Vault Admins, RIM Admins, and Submission Managers have access to create content plans in the Submissions tab, while Document Managers do not.

Core RIM Data

Wed, 09 Jul 2025 00:00:00 +0000

RIM Admins are responsible for creating and managing your organization’s product families and other core data. Creating the core data in advance can make it quicker and easier for your team to plan, track, author, review, and approve submission documents. Submission managers use this core data to create applications, submissions, and content plans.

Managing Core Product Data

Product families are the foundation of your core product data. After creating a product family, you can begin creating and adding product data to the product family using the following data structure:

Create a Clinical Study

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

If your organization uses Veeva Clinical Basics and has a RIM to Clinical connection, you can add existing studies created in Veeva Clinical Basics to your product families. If you do not have a RIM to Clinical connection, you can create new clinical studies to add to product families.

Create a Combined Product

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

A combined product is a product that combines multiple products into a single entity. First, create the combined product and add its details. Then, after saving the record, add each of the individual product components that make up the combined product.

Best Practice Prior to creating a combined product, create the necessary individual products and product variants.

Complete the following steps to create a combined product and add its product components:

Create a Content Plan

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Create a Document

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

Complete the following steps to upload a document:

Navigate to Submission Mgmt > Library tab, and click Create.
In the Create Document dialog, select Upload and click Continue.
On the Upload Files page, click Upload, select the document you want to upload, and click Open. Alternatively, drag and drop the document file you want to upload onto the Drag and drop files to upload here section on the Upload Files page.
To remove a document from the list of files to be uploaded, click the X button next to the document name in the right panel.
Select Classify documents now if you want to classify the document. Otherwise, select Classify documents later if you want to edit the document to add the classification at a later date.
If you selected Classify documents now, select the document’s classification from the Choose document type drop-down.
Click Next. A message is displayed on the Upload Files page when the files have been successfully uploaded.
Enter the Name and Title of the document.
From the eSignature Approval Required drop-down, select Yes if the document requires an eSignature, or select No if the document does not require an eSignature.
For documents using the Labeling type, select whether the labeling document is Approved for Use, Currently In Use, or Historical from the Additional Labeling Information drop-down.
Select the appropriate Product Family.
Optional: Search for and select any existing Applications and Submissions that the document is associated with.
Click Save. The system saves the document in a Draft state, generates a viewable rendition of the document, and displays the document’s details.

Create a Document from a Template

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

Complete the following steps to create a document from a template:

In the Submission Mgmt > Library tab, click Create.
In the Create Document dialog, select Document from Template and click Continue.
On the Create Document from Template page, select the document type from the Choose document type drop-down. Note that Vault only displays document types that have an associated template.
From the Choose template drop-down, select the template you want to use.
Click Next.
Enter a Name for the document.
Select the Product Family for the document.
Search for and select any Applications the document is associated with.
Search for and select any Submissions the document is associated with.
Click Save. The system saves the document in a Draft state, generates a viewable rendition of the document, and displays the document’s details. You can now edit the document, or route it through the Authoring/Review workflow for other users to edit the document with the appropriate content.

Create a Document Template

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

Document templates allow you to quickly create new documents from a configured template. When you create a new document from a template, Vault copies the template file and uses that copy as the source file for the new document. This process bypasses the content upload process and allows for more consistent document creation.

Create a Draft from an Approved Document

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

Complete the following steps to create a draft from an approved document:

From the Submission Mgmt > Library tab, open the approved document you want to create a draft from.
From the All Actions menu, select Create Draft.
Select an action in the Create Draft dialog:
- To create a new draft using the existing file, click Copy.
- To upload a new file, click Upload, select the document file you want, and click Open.
Optional: Enter a Version Description.
Click Create. Vault creates a new document in the Draft state and assigns it the next minor version.

Create a Nonclinical Study

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to add or create a nonclinical study for a product family:

On the Product Family page for the product family you want to create a nonclinical study for, click Add in the Nonclinical Study section. The Nonclinical Study dialog is displayed.
Determine whether to add an existing nonclinical study or create a new nonclinical study:
- To add an existing nonclinical study, select the checkbox for the nonclinical study you want to add.
- To create a new nonclinical study, click Create, enter the Nonclinical Study Number, select the Primary Product Family, enter any optional information, and click Save. Vault creates the nonclinical study and selects it in the dialog.
Click OK. Vault adds the nonclinical study to the product family.

Next Step: Continue creating product information and other core data for the product family.

Create a Placeholder Document

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

A placeholder document is a document record in Vault that does not yet have an uploaded document. You can create a placeholder document record now and upload a document file later.

Complete the following steps to create a placeholder document:

Create a Product

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to create a new product within a product family:

On the Product Family page for the product family for which you want to create a new product, click Add in the Products section.
Click Create in the Search: Product dialog.
From the Product Type list, select Product and click Continue.
In the Create Product dialog, enter the Product Name, select the Primary Product Family, and select the Manufactured Dosage Form.
Optional: If the product is a comparator product used in clinical trials, select Yes for Comparator Product. Otherwise, select No.
Click Save to create the product.
Ensure that the new product you created is selected in the Search: Product dialog and click OK. Vault adds the new product to the product family.

Next Step: Continue creating product information and other core data for the product family.

Create a Product Family

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to create a product family:

Navigate to the RIM Admin > Product Information tab and click Create.
On the Create Product Family page, enter the product family Name.
Optional: Enter the Alternate Name and Scientific Name.
Click Save. Vault creates the product family and displays the Product Family page.

Next Step: Create product information and other core data for the product family.

Create a Product Manufacturer

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to create a product manufacturer for a product:

On the Product Family page for the product family you want to create a product manufacturer for, click Add in the Product Manufacturer section. The Product Manufacturer dialog is displayed.
Determine whether to add an existing product manufacturer or create a new product manufacturer:
- To add an existing product manufacturer, select the checkbox for the product manufacturer you want to add.
- To create a new product manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the product manufacturer and selects it in the dialog.
Click OK. Vault adds the product manufacturer to the product family.

Next Step: Continue creating product information and other core data for the product family.

Create a Product Variant

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to create a product variant for a product:

On the Product Family page, click the Product Name of the product for which you want to create a variant.
On the Product page, click Product Variants in the left panel.
Click Create in the Product Variants section.
Enter the Product Variant name and select the Manufactured Dosage Form.
Click Save to create the product variant and add it to the product.

Next Step: Continue creating product information and other core data for the product family.

Create a Product Variant Active Substance

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Before adding an active substance to a product variant, you must first create the active substance for the product.

Complete the following steps to add an active substance to a product variant:

On the Product Family page, click the Product Name of the product that contains the variant to which you want to add an active substance.
On the Product page, click Product Variants in the left panel.
Click the Product Variant name. The Drug Product Variant page is displayed.
On the Drug Product Variant page, click Product Variant Active Substances in the left panel.
In the Product Variant Active Substances section, click Create.
In the Create Product Variant Active Substances dialog, select the Active Substance from the drop-down.
Click Save to add the active substance to the product variant.

Next Step: Continue creating product information and other core data for the product family.

Create a Product Variant Inactive Substance

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Before adding an inactive ingredient to a product variant, you must first create the inactive ingredient for the product.

Complete the following steps to add an inactive ingredient to a product variant:

On the Product Family page, click the Product Name of the product that contains the variant to which you want to add an inactive ingredient.
On the Product page, click Product Variants in the left panel.
Click the Product Variant name. The Drug Product Variant page is displayed.
On the Drug Product Variant page, click Product Variant Inactive Ingredients in the left panel.
In the Product Variant Inactive Ingredients section, click Create.
In the Create Product Variant Inactive Ingredient dialog, select the Inactive Ingredient from the drop-down.
Click Save to add the inactive ingredient to the product variant.

Next Step: Continue creating product information and other core data for the product family.

Create a Study Site

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to create a study site for a clinical study:

On the Product Family page, navigate to the Clinical Studies section and click the Clinical Study Number of the clinical study for which you want to create a study site.
On the Clinical Study page, enter the Site name.
Optional: Enter the Principal Investigator name and select a Country.
Click Save to create the study site and add it to the clinical study.

Create a Submission & Regulatory Objective

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

After the Application and Application Relationships are created, you can create a Submission and Regulatory Objective and associate the product family relationships to them using the Submission Wizard.

A submission represents the actual set of documents that will be sent to the Health Authority for their review. You can launch the Submission Wizard from the Application to easily create your Submission.

Create a Therapeutic Indication

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to add or create a therapeutic indication for a product family:

On the Product Family page for the product family you want to create a therapeutic indication for, click Add in the Therapeutic Indication section. The Therapeutic Indication dialog is displayed.
Determine whether to add an existing therapeutic indication or create a new therapeutic indication:
- To add an existing therapeutic indication, select the checkbox for the therapeutic indication you want to add.
- To create a new therapeutic indication, click Create, enter the Name of the therapeutic indication, and click Save. Vault creates the therapeutic indication and selects it in the dialog.
Click OK. Vault adds the therapeutic indication to the product family.

Next Step: Continue creating product information and other core data for the product family.

Create a User

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin

When you create a new Veeva RIM Basics user for your organization, you can select the user’s security profile and application license types.

If a user record for one of your users already exists in one of your other domains, such as Clinical Basics or Quality Basics, you can select that existing user to automatically populate some of the user’s information. See user types for more info.

Create an Active Substance

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to add or create an active substance for a product family:

On the Product Family page for the product family you want to create an active substance for, click Add in the Active Substances section. The Active Substance dialog is displayed.
Determine whether to add an existing active substance or create a new active substance:
- To add an existing active substance, select the checkbox for the active substance you want to add.
- To create a new active substance, click Create, enter the Substance Name, select the Primary Product Family, and click Save. Vault creates the active substance and selects it in the dialog.
Click OK. Vault adds the active substance to the product family.

Next Step: Continue creating product information and other core data for the product family.

Create an Active Substance Manufacturer

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to create a manufacturer for an active substance:

On the Product Family page, click the Substance Name of the active substance to which you want to add a manufacturer.
On the Active Substance page, click Manufacturers in the left panel.
Click Add in the Manufacturers section. The Manufacturer dialog is displayed.
Determine whether to add an existing manufacturer or create a new manufacturer:
- To add an existing manufacturer, select the checkbox for the manufacturer you want to add.
- To create a new manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the manufacturer and selects it in the dialog.
Click OK. Vault adds the manufacturer to the active substance.

Next Step: Continue creating product information and other core data for the product family.

Create an Application

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

A regulatory application is a formal submission comprising a set of documents made to a regulatory authority, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union, to obtain approval for the development, testing, or marketing of a product.

Create an Application Relationship

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

After the Application has been created, the next step is to create the application relationships using the core data set up by the Vault Admin.

This work instruction applies to Product Families, Products, Active Substances, Inactive Ingredients, Therapeutic Indications, Clinical Studies, and Nonclinical Studies.

Create an External Hyperlink

Wed, 09 Jul 2025 00:00:00 +0000

While authoring submission content, you can create document permalinks within the source document that navigate users to other content within Vault.

To create an external hyperlink:

Open the document where you want to add the hyperlink. To open the document right from the Content Plan, click the open in pop-up icon.
Select the View/Hide Annotations icon to enter annotation mode.
Select the Permalink Link tool.

Create an Inactive Ingredient

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to add or create an inactive ingredient for a product family:

On the Product Family page for the product family you want to create an inactive ingredient for, click Add in the Inactive Ingredient section. The Inactive Ingredient dialog is displayed.
Determine whether to add an existing inactive ingredient or create a new inactive ingredient:
- To add an existing inactive ingredient, select the checkbox for the inactive ingredient you want to add.
- To create a new inactive ingredient, click Create, enter the Inactive Ingredient Name, select Yes or No depending on whether the inactive ingredient is a Novel Excipient, and click Save. Vault creates the inactive ingredient and selects it in the dialog.
Click OK. Vault adds the inactive ingredient to the product family.

Next Step: Continue creating product information and other core data for the product family.

Create an Inactive Ingredient Manufacturer

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to create a manufacturer for an inactive ingredient:

On the Product Family page, click the Substance Name of the inactive ingredient to which you want to add a manufacturer.
On the Inactive Ingredient page, click Manufacturers in the left panel.
Click Add in the Manufacturers section. The Manufacturer dialog is displayed.
Determine whether to add an existing manufacturer or create a new manufacturer:
- To add an existing manufacturer, select the checkbox for the manufacturer you want to add.
- To create a new manufacturer, click Create, enter the Manufacturing Site Name, select the Country, and click Save. Vault creates the manufacturer and selects it in the dialog.
Click OK. Vault adds the manufacturer to the inactive ingredient.

Next Step: Continue creating product information and other core data for the product family.

Create, Export, and Lock a Binder

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Managers

Note: This work instruction is intended to be used when you are using a third party for publishing, rather than Veeva RIM Basics: Submissions Publishing.

Once all content plan items are Complete and version-locked, you can create a binder from the content plan that can be published outside of Vault. You can create a binder of an entire content plan or only a specific section of the content plan. Once you have created a binder, you can export the binder, which creates a ZIP file with PDFs of each document in the binder.

Deactivate or Reactivate an Application

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Complete the following steps to deactivate or reactivate an application:

In the Submission Mgmt > Applications tab, click the Application Name of the Active application you want to deactivate.
From the Workflow Actions menu, select Change State to Inactive. Vault displays a dialog asking you to confirm that you want to change the state to Inactive.
Click Yes. Vault updates the application status to Inactive.
To reactivate an Inactive application, select Change State to Active from the Workflow Actions menu. Vault displays a dialog asking you to confirm that you want to change the state to Active.
Click Yes. Vault updates the application status to Active.

Delete a Submission Relationship Record

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

To delete a submission relationship record:

Navigate to the Submission record and open the applicable Submission Relationships section.
Click Delete from the Actions menu of the record you want to delete.

Troubleshoot Errors

If you receive an error when trying to delete a submission relationship record, it may be because it is used by one or more Content Plan Item records. You must first delete the corresponding section in the Content Plan (even if it’s inactive).

Edit a Document

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

Complete the following steps to edit a document:

From the Submission Mgmt > Library tab, open the document you want to edit.
To classify an unclassified document, click Classify in the Information panel, select the document’s Type, Subtype, and Classification, and click OK. Vault adds the document’s classification.
To reclassify a document, click Reclassify in the Information panel, select a new Type, Subtype, and Classification, and click OK. Vault updates the document’s classification.
To upload a file to a placeholder document, click Upload File, select the file you want to upload, and click Upload. Alternatively, drag and drop the file you want to upload onto the This placeholder has no content section on the document page.
To edit a document’s information click Edit Fields in the Information panel heading, edit the information as needed, and click Save. Vault saves the updated document information.

Edit Product Family Information

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: RIM Admin

Complete the following steps to edit product family information:

On the Product Family page, click Edit.
Edit the product family Name, Alternate Name, or Scientific Name as needed.
Click Save to save your changes.
To edit other information associated with the product family, navigate to the appropriate section and click the Name of the item you want to edit.
On the item’s page, click Edit, edit the information as needed, and click Save to save your changes.

Export a Submission

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

You are also able to export a dossier for each submission and select specific components within the eCTD structure, if needed. Because the export maintains the same folder structure used during import, you can use this option to leverage exported submissions or components for other regions. Exporting can also simplify the process of distributing dossiers with local affiliates or publishing partners.

Extract a Commitment from a Document

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

As a condition of approving a pharmaceutical product to be marketed, or approving changes to the products, a Health Authority may require changes to a Submission, or require that additional information be provided in areas such as safety, efficacy or optimal dosage. These are regulatory commitments.

Extract a Health Authority Question from a Document

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

As submissions are sent to the Health Authority, they may require you to provide answers to questions. In Veeva RIM Basics, you can manage communication with Health Authorities by tracking incoming questions and responses, and track the status of each individual question/response.

Generate the Application Chronology Report

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

The Application Chronology Report helps you track Application Submissions, Regulatory Objectives, Commitments, and Correspondences in chronological order. It gives you a timeline view of your application all in one place.

To activate items in a content plan:

Navigate to the application and select Application Chronology Report from the All Actions menu.

Import a Submission

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

If your submission is smaller than 4 GB, you can import it to the Submissions Archive directly from the file’s local storage location. If your submission is larger than 4 GB, you must first upload it to Vault’s file staging using an FTP client.

Import Submissions via File Staging

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

You can upload and import submissions that have been staged to File Staging.

When using your Vault’s file staging to perform a Submissions Archive import, the top level folder should be named “Submissions Archive Import”, followed by the Application sub-folder, and then individual Submission sub-folders containing the content of your submissions unzipped.

Lock a Content Plan

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

When all documents for a submission are version locked to the latest steady state, the next step is to lock the content plan by changing its state to Final in preparation for submitting to the Health Authority.

To lock a content plan:

Manage the eCTD Lifecycle in a Content Plan

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

To apply a lifecycle to a document in a content plan, the corresponding content plan item must be in the Ready for Use state.

Click into the XML Operation field for the content plan item.
Select the appropriate operation (e.g. Replace), and click out of the field to save.

Managing Documents

Wed, 09 Jul 2025 00:00:00 +0000

The Submission Mgmt > Library tab allows Vault Admins, Submission Managers, and Document Managers to create, edit, and view documents throughout the document lifecycle.

Document Management Overview

Managing your documents in Veeva RIM Basics follows a general process:

Create and classify your documents.
Author and review your documents.
Approve your documents to indicate that they are ready for submission.

Document Statuses

Documents in Veeva RIM Basics use the following statuses:

Draft: The document has been created, but it is not approved or in an active workflow.
In Authoring/Review: The document is currently in the Authoring/Review workflow.
In Approval: The document has been sent for approval.
Approved: The document has been approved manually or through an Approval workflow.
Superseded: A newer major version of the document has been created.
Obsolete: The document is obsolete and is no longer applicable.

Document Versions

When you first create a document, it is assigned the minor version 0.1. Each time the document is edited and checked back in during the Authoring/Review workflow, Vault increments the version by 0.1. When the document is approved, Vault assigns the document the major version 1.0. For example, if a document is in minor version 0.6, Vault assigns the document the major version 1.0 when it is approved.

Match Documents in a Content Plan

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Navigating RIM Basics

Wed, 09 Jul 2025 00:00:00 +0000

RIM Basics Tab Collections

The Tab Collections menu allows you to switch between different collections of tabs in Vault. Submission Managers and Document Managers have access to the Submission Management (Mgmt) tab collection only, while Vault Admins have access to the Submission Mgmt, RIM Admin, and Admin tab collections. Your role determines which tabs are available to you in each tab collection you have access to.

Submission Mgmt Tab Collection

Node Extensions

Wed, 09 Jul 2025 00:00:00 +0000

EU Submissions require node extensions instead of Study Tagging Files (STFs). To publish node extensions:

Set the Create Node Extensions field on the Submission record to Yes
Define node extensions on the Content Plan by setting the XML Element Name field to node-extension
Enter a value in the XML Title field on the Content Plan

Note The title of a node extension or STF is controlled by the Content Plan Title field. The title field has a limit of 1500 characters. However, for publishing of STF and node extensions a hard limit of 255 characters is enforced.

Perform an Approval Task

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

When you have been assigned an Approval task, Vault displays the task on the Submission Mgmt > Home tab.

When completing an Approval task, you can either approve the document or reject it by selecting a verdict of Approved or Not Approved.

Perform Authoring/Review

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

When you have been assigned an Authoring/Review task, Vault displays the task on the Submission Mgmt > Home tab.

Complete the following steps to complete an Authoring/Review task:

From the Submission Mgmt > Home tab, select the All Tasks view to view your assigned tasks.
Click Show more on the task to view additional task information.
Click the document name or click Continue on the Authoring/Review task you need to complete. Vault opens the document and displays a task banner with the task due date, instructions, and task owner.
Review and edit the document as needed. The steps for editing the document are different depending on whether your organization uses collaborative authoring.
Once you have edited and reviewed the document and it is checked back into Vault, click Complete in the task banner. Vault displays a dialog asking you to confirm that you have completed the task.
Click Complete in the dialog. Vault updates the document status to Draft, removes the task from your Home tab, and sends a notification to the task initiator to indicate that the task is complete.

Prepare a Submission for Import

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

To prepare a submission for import, locate the submission’s ZIP file from your third-party publishing tool that contains the submission content you submitted to the Health Authority.

We recommend creating one (1) folder in your storage location for each application and storing each submission’s ZIP file and unzipped contents in a submission folder inside the application folder. This folder structure helps ensure that all submissions for an application are in a central location, which makes it easier to locate the appropriate submission folder when sending a submission to your third-party publishing tool and when importing a submission to RIM Basics: Submissions Archive.

Regulatory Objectives

Wed, 09 Jul 2025 00:00:00 +0000

After you’ve created an application, you can use that application to create regulatory objectives, which are then used to track one or more submissions.

To facilitate data integrity and ease data management across your submissions, RIM Basics includes the Submission Wizard. You can use the Submission Wizard to create or update regulatory objectives within an application. The Submission Wizard can help Regulatory Operations Managers ensure that the related product family data is accurate and complete.

Retarget or Suppress an External Hyperlink

Wed, 09 Jul 2025 00:00:00 +0000

Link Evaluator is a useful tool for reviewing any links within a published submission and resolving any validation results that stem from broken links.

Example Validation Result

You can retarget a link to a different document or document location, or suppress (remove) the link from the published document.

Retarget a Link

To retarget a link:

Navigate to the content plan and locate the document. Select Evaluate Links from the Content Plan item Actions menu.

Review & Resolve a Validation Result

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.

When your submission content is validated against the specific rules for the agency specified for the application, validation results may be generated.

Note: Your submission can only be validated when continuous publishing is turned on.

RIM Basics

Wed, 09 Jul 2025 00:00:00 +0000

RIM Basics: Submissions is a preconfigured system that allows your organization to plan, author, review, approve, and assemble regulatory submission documents, such as clinical study reports, manufacturing information, nonclinical reports, and labeling.

RIM Basics: Submissions Publishing streamlines the preparation, management, publishing, hyperlinking, and validation of regulatory submissions for global health authorities. Note: Publishing requires an additional license.

RIM Basics: Submissions Archive is an optional add-on that allows you to view and import published submissions and health authority correspondence.

RIM Basics Jobs

Wed, 09 Jul 2025 00:00:00 +0000

Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period.

Job Name	Description	Schedule
Auto-Train Models	Allows the RIM Bot to actively train the machine learning model to learn from your inputs, preparing it to intelligently process data of the document classification type when there are 1,500 or more Steady state documents contained in your Vault.	Runs daily at 1:00 AM in the Vault’s timeline.
Delete Inactive Content Plans	Deletes unused, inactive Content Plan and Content Plan Item records with an Actual Submission Date, Last Published Date, or Event Complete Date at least 365 days earlier than the current date.	Runs daily at 12:00 AM in the Vault’s timezone.
Match EDL Items to Documents	Automatically matches Expected Document List (EDL)/Submission Content Plans (SCP) items to appropriate documents. This will also update the colored circle harvey balls to denote the status of content plan items.	Runs daily at 1:00 AM in the Vault’s timezone.
Clean Up Submissions Archive Orphaned Files	Deletes documents that should belong to a Submissions Archive dossier, but aren’t connected to one. This will occur when a Submission Archive is removed and the corresponding documents then will be purged.	Runs daily at 5:00 AM in the Vault’s timezone.
Submissions Archive Harmonization	Corrects broken references and eCTD placeholder files within a submission.	Runs daily at 4:00 AM in the Vault’s timezone.
User Account Activation	Automatically activates user accounts when the Activation Date has been reached.	Runs daily at 12:00 AM in the Vault’s timezone.

If you’re unsure of your Vault’s timezone, you’ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault’s timezone.

RIM Basics: Submissions

Wed, 09 Jul 2025 00:00:00 +0000

RIM Basics: Submissions provides an end-to-end solution for managing regulatory submissions. It helps organizations streamline the complex process of preparing, managing, submitting, and maintaining regulatory documentation required by global health authorities.

Benefits of using RIM Basics: Submissions

Provides a single source of truth for tracking the progress of regulatory submissions globally.
Includes purpose-built tools optimized for regulatory processes.
Facilitates compliance with global and regional regulatory requirements.
Allows easier collaboration and insight into submission progress.

RIM Basics: Submissions Archive

Wed, 09 Jul 2025 00:00:00 +0000

RIM Basics: Submissions Archive is an optional add-on to RIM Basics: Submissions that allows you to view and import published submissions and health authority correspondence.

RIM Basics: Submissions Archive with Publishing is kept up-to-date with your latest content, once you turn on continuous publishing.

RIM Basics: Submissions Publishing

Wed, 09 Jul 2025 00:00:00 +0000

RIM Basics: Submissions Publishing provides an end-to-end solution for managing regulatory submissions. It helps organizations streamline the complex process of preparing, managing, publishing, validating, submitting, and maintaining regulatory documentation required by global health authorities. Note: Publishing requires an additional license.

Benefits of using RIM Basics: Submissions Publishing

Provides a single source of truth for tracking the progress of regulatory submissions globally.
Includes purpose-built tools optimized for regulatory processes.
Facilitates compliance with global and regional regulatory requirements.
Allows easier collaboration and insight into submission progress.
You and your team can start publishing and validating your submission against agency-specific rules early in the process.
Catch potential errors prior to submitting, saving time and frustration as the submission due date approaches.
Once you start publishing, Submissions Archive Viewer stays up-to-date with your latest content.

Send a Document for Approval

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

If a document does not require an eSignature, you can send it to a user or group for approval without requiring the users to enter their credentials when approving or rejecting the document.

Complete the following steps to start the Approval workflow and assign the Approval task:

Send a Document for Authoring/Review

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

Once a document is ready for review or needs to have its content edited, you can route the document through the Authoring/Review workflow.

You can edit a document’s contents using collaborative authoring if it is enabled by your organization, or you can edit a document without collaborative authoring by checking it out, editing it, and checking it back in.

Send a Document for eSignature

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

If a document requires an eSignature for approval, it must go through the eSignature Approval workflow to capture the necessary signatures before its status is changed to Approved. You cannot manually approve a document that requires an eSignature for approval.

Submission Relationships - Impact to SCP Structure

Wed, 09 Jul 2025 00:00:00 +0000

Relationship	Impact to SCP Structure
Clinical Study	5.3.1.1 – Biopharmaceutical > Bioavailability (BA)
	5.3.1.2 – Biopharmacetical > Comparative Bioavailability (BA) and Bioequivalence (BE)
	5.3.1.3 – Biopharmacetical > In Vitro - In Vivo Correlation
	5.3.1.4 – Biopharmacetical > Bioanalytical and Analytical Methods
	5.3.2.1 – Pharmacokinetics using human biomaterials > Plasma Protein Binding
	5.3.2.2 – Pharmacokinetics using human biomaterials > Hepatic Metabolism and Drug Interactions
	5.3.2.3 – Pharmacokinetics using human biomaterials > Other Human Biomaterials
	5.3.3.1 – Human Pharmacokinetics (PK) > Healthy Subject Pharmacokinetic (PK) and Initial Tolerability
	5.3.3.2 – Human Pharmacokinetics (PK) > Patient Pharmacokinetic (PK) and Initial Tolerability
	5.3.3.3 – Human Pharmacokinetics (PK) > Intrinsic Factor Pharmacokinetic (PK)
	5.3.3.4 – Human Pharmacokinetics (PK) > Extrinsic Factor
	5.3.3.5 – Human Pharmacokinetics (PK) > Population Pharmacokinetic (PK)
	5.3.4.1 – Pharmacodynamics (PD) > Healthy Subject Pharmacodynamics (PD) and PK/PD 5.3.4.2 – Pharmacodynamics (PD) > Patient Pharmacodynamics (PD) and PK/PD
	5.3.5.1 – [Indication] > Efficacy and Safety > Controlled Clinical Studies
	5.3.5.2 – [Indication] > Efficacy and Safety > Uncontrolled Clinical Studies
	5.3.5.3 – [Indication] > Efficacy and Safety > Analyses of Data
	5.3.5.4 – [Indication] > Efficacy and Safety > Other Studies
	5.3.6 – Postmarketing Experience
Nonclinical Study	4.2.1.1 – Pharmacology > Primary Pharmacodynamics
	4.2.1.2 – Pharmacology > Secondary Pharmacodynamics
	4.2.1.3 – Pharmacology > Safety Pharmacology
	4.2.1.4 – Pharmacology > Pharmacodynamic Drug Interactions
	4.2.2.1 – Pharmacokinetics > Analytical Methods and Validation Reports
	4.2.2.2 – Pharmacokinetics > Absorption
	4.2.2.3 – Pharmacokinetics > Distribution
	4.2.2.4 – Pharmacokinetics > Metabolism
	4.2.2.5 – Pharmacokinetics > Excretion
	4.2.2.6 – Pharmacokinetics > Pharmacokinetic Drug Interactions
	4.2.2.7 – Pharmacokinetics > Other Pharmacokinetic
	4.2.3.1 – Toxicology > Single Dose Toxicity
	4.2.3.2 – Toxicology > Repeat Dose Toxicity
	4.2.3.3.1 – Toxicology > In vitro Genotoxicity
	4.2.3.3.2 – Toxicology > In vivo Genotoxicity
	4.2.3.4.1 – Toxicology > Long Term Carcinogenicity
	4.2.3.4.2 – Toxicology > Short or Medium Term Carcinogenicity
	4.2.3.4.3 – Toxicology > Other Carcinogenicity 4.2.3.5.1 – Toxicology > Fertility and Early Embryonic Development
	4.2.3.5.2 – Toxicology > Embryofetal Development
	4.2.3.5.3 – Toxicology > Prenatal and Postnatal Development
	4.2.3.5.4 – Toxicology > Studies in Which the Offspring are Dosed or Evaluated
	4.2.3.6 – Toxicology > Local Tolerance
	4.2.3.7.1 – Toxicology > Antigenicity
	4.2.3.7.2 – Toxicology > Immunotoxicity
	4.2.3.7.3 – Toxicology > Mechanistic
	4.2.3.7.4 – Toxicology > Dependence
	4.2.3.7.5 – Toxicology > Metabolites
	4.2.3.7.6 – Toxicology > Impurities
	4.2.3.7.7 – Toxicology > Other Toxicity
Products	2.3.P – Drug Product
	3.2.P – Drug Product
	3.2.A.1 – Facilities and Equipment
	3.2.A.2 - Adventitious Agents Safety Evaluation
Active Substances	2.3.S – Drug Substance
	3.2.S – Drug Substance
	3.2.A.1 – Facilities and Equipment
	3.2.A.2 - Adventitious Agents Safety Evaluation
Inactive Ingredients	3.2.P.4 Control of Excipients
	3.2.A.3 Novel Excipients
Indications	2.7.3 Summary of Clinical Efficacy
	5.3.5 Reports of Efficacy and Safety Studies

Submissions

Wed, 09 Jul 2025 00:00:00 +0000

After you’ve created an application, you can use that application to create submissions, which are then used to create submission content plans.

To facilitate data integrity and ease data management across your submissions, RIM Basics: Submissions includes the Submission Wizard. You can use the Submission Wizard to create or update submissions within an application. The Submission Wizard can help Regulatory Operations Managers ensure that the related product family data is accurate and complete.

Submit to Health Authority & Archive Submission

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Prior to submission, make sure that you have:

If configured in your vault, your submission can be sent directly to the health authority through the electronic gateway. You can also download your submission. After you have made your submission to the health authority, record the actual submission date.

Turn Off Continuous Publishing

Wed, 09 Jul 2025 00:00:00 +0000

This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Take care when deciding to turn off continuous publishing. Turning it off and then back on again requires a full delete and republish of the entire submission.

Turn On Continuous Publishing

Wed, 09 Jul 2025 00:00:00 +0000

This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

The decision of when to turn on continuous publishing is up to you but Veeva recommends you turn it on as early as is reasonable. For example, when you’ve been authoring and matching documents, adding hyperlinks, and you want to view your submission at this point.

Update a Rendition

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager, Document Manager, Document Participant

If you have edited a rendition outside of Veeva Basics (e.g. to add bookmarks), you can upload the new rendition.

To update a rendition:

From within the document thas has had its rendition updated, select the Document Files () tab.

Version Lock Matched Documents in a Content Plan

Wed, 09 Jul 2025 00:00:00 +0000

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

A solid orange icon means the document has been approved but not yet version locked. You can version lock an individual document, all eligible documents in a section or all eligible documents in the content plan.

View Submission Content in Viewer

Wed, 09 Jul 2025 00:00:00 +0000

This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

Once you enable continuous publishing, you can go into Submissions Archive Viewer to see your submission, with all the documents and hyperlinking.

To view submission content in Viewer:

RIM Basics: Document Manager

Wed, 04 Jun 2025 00:00:00 +0000

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RIM Basics: Document Participant

Wed, 04 Jun 2025 00:00:00 +0000

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RIM Basics: RIM Admin

Wed, 04 Jun 2025 00:00:00 +0000

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RIM Basics: RIM Admin with Publishing

Wed, 04 Jun 2025 00:00:00 +0000

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RIM Basics: Submission Manager

Wed, 04 Jun 2025 00:00:00 +0000

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RIM Basics: Submission Manager with Publishing

Wed, 04 Jun 2025 00:00:00 +0000

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RIM Basics: Vault Admin

Wed, 04 Jun 2025 00:00:00 +0000

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RIM Basics: Vault Admin with Publishing

Wed, 04 Jun 2025 00:00:00 +0000

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Mon, 01 Jan 0001 00:00:00 +0000