Creating CMC (Chemistry, Manufacturing, and Controls) documentation requires a deep understanding of technical and regulatory aspects. Every stage of a product’s lifecycle, from development to post-marketing updates, demands specialized expertise. Crafting high-quality CMC documentation can be challenging.
Celegence provides comprehensive support in authoring and reviewing CMC technical packages. Our extensive experience spans preparing and reviewing documents for briefing packages, IND/IMPD and MAA/BLA submissions, as well as post-approval variations and amendments. This expertise is demonstrated by our numerous successful submissions and positive regulatory outcomes.
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