You can now generate eCTD compliance packages directly from PromoMats Basics. This new functionality supports both pre-clearance and post-marketing submissions.
Regulatory Submissions is a new tab collection that allows Submissions Coordinators to manage Product Information, Compliance Packages, Health Authority Documents, and key data for the eCTD compliance package generation process.
Users with the Submission Coordinator system assignment now have expanded permissions related to eCTD and Product Data.
Set Up Core Data
Prior to generating an eCTD package, the Submission Coordinator must first set up the Applicant and Application data.
Applications
Applications is a new tab on the Regulatory Submissions tab collection that allows Submissions Coordinators to create Applications, Applicants, Contacts, and Submissions. The Submission Coordinator will need to create the necessary Application, Applicant, Contact (Responsible Official), and Submissions before generating the eCTD compliance package.
Product Information
Product Information is a new tab on the Regulatory Submissions tab collection that allows Submissions Coordinators to create Product Families and Product Forms. Vault Admins and PromoMats Admins can associate Brands to Product Families.
In this release, Product Family will not display on documents in PromoMats Basics and you do not need to use Product Families at this time. This feature was added to prepare for the support of the RIM<>PromoMats Connection planned for a future release.
How to Generate the eCTD Package
Watch this video (3 min) to learn how to generate the eCTD package after the 25R3 release.
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