Kenvue piloted Celegence's CAPTIS generative AI to draft CMC Module 3 submission documents.

CMC Module 3 documents took weeks of manual work and drew on inconsistent source data. In a six-month pilot, Celegence's CAPTIS platform generated submission-ready CMC documentation for FDA and MHRA filings, including from scanned input files. The page reports 80-95% alignment with previously approved submissions and about 60% faster draft turnaround.

Celegence is a regulatory affairs and medical writing firm with a generative AI platform, used for CMC submission drafting and medical device compliance documents

This sits in the Ship stage of the AI use-case lifecycle: Named examples from the vendors pharma teams use to get an AI system live inside a real, regulated production workflow — validation, CRM, safety and clinical systems of record.