Best Practices for Creating Submission Ready Documents

eCTD is not just an electronic version of a paper dossier but a system for presenting and organizing information. Read on to learn more about best practices for creating submission-ready regulatory documents. 

How to Create Submission-Ready Regulatory Documents


Adopt an eCTD format and integrate it into a report format. Keep in mind the 4 subgroups:

  • Clinical
  • Non-clinical
  • CMC
  • Labeling


Institute a formal reporting process for the following documents:

  • Process Development
  • Process Characterization
  • Process Validation
  • Control Strategy


Think ahead and keep your regulatory submission in mind when characterizing process, doing risk assessments, and determining critical process parameters and critical raw materials.


Utilize existing e-Notebook software for ease of searching for reference documents and experiments.


Adopt QbD best practices when developing processes.

Key Advantages of utilizing eCTD

  • Reduce costs
  • Increased value
  • Streamline workflows
  • Facilitate collaboration
  • Re-use components
  • Support lifecycle management
  • Effective mechanism for information sharing
  • Save time

Best Practices For Creating Submission Ready Documents

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.