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.
Adopt an eCTD format and integrate it into a report format. Keep in mind the 4 subgroups:
Institute a formal reporting process for the following documents:
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.
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