Authors: Kristen Brotzman, Brenda Taylor, and Steve Sibley
Summary:
Every marketing application for a new therapeutic product includes thousands of files, millions of data points, and countless interconnections. This white paper provides a roadmap for understanding and managing document dependencies across the five modules of the electronic Common Technical Document (eCTD).
Drawing on Certara’s experience supporting more than 400 marketing applications, this guide helps medical writers, submission leads, and regulatory project managers understand document dependencies throughout the drug development process—a fundamental step in effectively planning, crafting, and maintaining submission documents to ensure accuracy, consistency, and regulatory success.
Why read this paper:
Each regulatory submission is a complex network of interrelated documents. Overlooking these interdependencies can lead to inconsistencies, missed milestones, and costly delays.
This white paper helps teams:
- Avoid duplication and inconsistency through dependency mapping
- Plan realistic timelines that account for data availability and review cycles
- Ensure coherent messaging across Modules 1–5
- Identify and map dependencies for all key submission documents, including:
- Clinical Study Report
- General Investigational Plan
- Integrated Summary of Immunogenicity
- Integrated Summary of Safety
- And more!
- Improve collaboration across authoring teams
- Reduce rework and QC errors
- Enhance the overall quality and consistency of your submissions
Bonus access: A visual reference for document relationships across the submission lifecycle
The white paper includes a comprehensive visual appendix that illustrates document relationships across the submission lifecycle.
Ensure your next submission is cohesive, consistent, and compliant.
Ensure your next submission is cohesive, consistent, and compliant. Fill out the form to download the white paper!
