Best Practices for Creating Submission Ready Documents

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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

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

  • Clinical
  • Non-clinical
  • CMC
  • Labeling

Institute

Institute a formal reporting process for the following documents:

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

Think

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

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

Standardize

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

Need help creating submission-ready regulatory documents? Pharmatech Associates can help! Contact us today.

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