EMA eSub Publishing Gateway Setup

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:

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.

  1. Account Request
  2. Gateway Profile Setup
  3. Prepare Test Submissions
  4. Production Gateway Profile Setup