Create an eCTD Compliance Package

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Last updated: Dec 5, 2025
Who can complete this task? Veeva PromoMats Basics: Submission Coordinator

To create an eCTD compliance package:

  1. Navigate to Regulatory Library > Materials.

    Screenshot step 1

  2. Click the Actions menu and perform a Bulk Action.

    Screenshot step 2

  3. Select the document to create an eCTD compliance package for, and click Next.

    Screenshot step 3

  4. Select the compliance package type, and click Next.

    Screenshot step 4

  5. Fill in all required fields, and click Next.

    Screenshot step 5

Note The Reg Comments to FDA field is optional, but will populate directly into form 2253.
  1. When all required fields are filled out, click Next, then Finish to create the eCTD compliance package.

What is the next step?

Review and Submit an eCTD Compliance Package