Every marketing application, whether a New Drug Application (NDA) or Biologics License Application (BLA) to the U.S. FDA, a Marketing Authorisation Application (MAA) or EU Type II variation to the EMA, or submissions to other global authorities, includes thousands of files, millions of data points, and complex interdependencies. This white paper provides a practical roadmap for understanding and managing document dependencies across all five modules of the electronic Common Technical Document (eCTD).
WHITE PAPER
A Practical Guide to Managing Document Dependencies in eCTD Submissions
Achieve clear, consistent, and compliant eCTD submissions through dependency mapping
Key takeaways for smarter eCTD submissions
Each regulatory submission comprises a complex set of interrelated documents. Failure to identify and manage these interdependencies may result in inconsistencies, misaligned content, schedule impacts, and additional rework.
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 (CSR)
- Clinical Overview (CO)
- Summary of Clinica Efficacy (SCE)
- Integrated Summary of Safety (ISS)
- And additional key submission documents
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. Fill out the form and download the white paper!
Download the white paper
Simply fill out the form and download the expert-led paper for free!
About the authors
Kristen Brotzman, ELS
Associate Director, Regulatory Project Management
Ms. Brotzman brings over 12 years of experience in the pharmaceutical and regulatory industry as a technical editor and project manager. She partners with cross-functional teams to prepare high-quality global submissions and maintain lasting client relationships. An innovative and solutions-oriented professional, she uses technology to streamline timelines, content plans, and dashboards across a range of submission types. She also has extensive experience leading teams, mentoring colleagues, and developing training programs. Ms. Brotzman is conversational in Spanish and previously held the Certified Editor in the Life Sciences (ELS) credential for 10 years.
Brenda Taylor
Director of Global Submissions
Brenda Taylor is a Director of Global Submissions at Certara. She has over 20 years of experience in the biotechnology and pharmaceutical industry. She has led regulatory strategy and submission management activities to support pharmaceutical development and manufacturing, with an emphasis on Initial New Drug (IND) applications and marketing applications. Brenda’s research background in microbiology and immunology includes design and performance of nonclinical studies. Her therapeutic areas of expertise include oncology, cardiovascular, and anti-infective agents, spanning both small-molecule drugs and biologics.
Steve Sibley
Vice President Regulatory Strategy
With a career spanning more than 30 years in the pharmaceutical industry, Steve Sibley provides regulatory writing consulting services and leads the global submissions service line within Certara Drug Development Solutions (CDDS). He has led global submission teams and authored critical documentation on more than 45 marketing applications and more than 30 investigational drug applications. Sibley has particular expertise in briefing documents, regulatory defense, and submission planning. Sibley’s work has covered the full range of therapeutic areas and program types, with a particularly strong background in oncology, cardiology, and rare diseases, including participation in health authority meetings and advisory committee meetings. His experience is truly global, having worked in project teams encompassing the United States, the European Union, Australia, and Asia. Sibley draws on his substantial industry knowledge and leadership skills to mentor and train other submission leads.
About Certara
Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.
From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
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