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AI in regulatory submissions: what RAG changes for filings
A major biopharmaceutical company put a peer-reviewed paper out in 2025 describing a tool that uses large language models to draft the CTD Module 2.3 Quality Overall Summary on its own. The model does not make things up. It reads several thousand pages of Module 3 quality data and boils them down into the structured QOS narrative with retrieval-augmented generation. This is the clearest public sign yet that AI has entered GxP regulatory filing. Why the quality overall summary is the right first job for AI The Common Technical Document is the format regulators use to review drug applications in the major markets. Module 3 is where the raw quality…
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FDA CMC Requirements: What Reviewers Actually Check
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