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

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