This breakthrough was demonstrated in a pioneering pilot project with Kenvue, marking a transformative moment for regulatory writing in the pharmaceutical sector.
“At Celegence, we believe that generative AI is not just a technological advancement: it’s a transformative force that redefines regulatory writing in the life sciences."
"By automating complex document creation like CMC Module 3, we empower regulatory teams to achieve unprecedented speed, accuracy, and compliance. This breakthrough enables our clients to focus on strategic innovation while ensuring their submissions meet the highest global standards."
"The future of regulatory writing is here and Celegence is proud to lead the way.” said Punya Abbhi, Chief Operating Officer, Celegence.
Industry first automation of CMC Module 3
In a 6-month pilot partnership with Kenvue, Celegence’s CAPTIS platform automatically generated critical CMC Module 3 documents for FDA and MHRA submissions.
This achievement represents the first time generative AI has been proven to deliver high-quality, submission-ready CMC documentation at scale - an area historically dominated by labour-intensive, manual processes.
Key results from the pilot:
- 80–95% alignment with previously approved submissions: AI-generated drafts closely matched existing, regulator-approved documents, requiring minimal manual edits
- 60% faster draft turnaround: Tasks that previously took weeks were completed in minutes, freeing regulatory teams to focus on strategic review and value-added activities
- superior consistency and accuracy: CAPTIS standardised tables, terminology, and formatting across all sections, reducing the risk of common errors
- seamless data integration: The platform handled fragmented and variably structured input files — including scanned documents and handwritten notes —extracting and organising usable information with ease.
"The AI drafts were indistinguishable from our own," said Jason Mattis, Global Head, CMC Regulatory Affairs at Kenvue.
"In fact, I preferred the AI-generated tables; they were cleaner and easier to follow. Other generic AI writing tools we piloted did not match the performance of Celegence’s purpose-built solution."
Addressing longstanding industry pain points
Regulatory writing teams have traditionally struggled with:
- Manual, Time-Intensive Authoring: Weeks spent compiling and aligning data from disparate sources.
- Inconsistent Source Data: Non-standardised documents from CMOs, clinical sites, and R&D teams.
- Compliance and Regulatory Risk: Increasing demands from authorities such as the FDA and EMA for consistency and speed.
- Data Quality and Traceability: Difficulty ensuring submissions are traceable to original sources, risking costly review delays.
Celegence’s CAPTIS platform directly addresses these challenges, setting a new standard for efficiency, accuracy, and compliance in regulatory submissions.
Why this matters now
AI-driven regulatory writing is no longer a future aspiration - it is a practical reality. With CAPTIS, Celegence empowers regulatory teams to
- Accelerate Literature Reviews: Automate evidence synthesis and ensure traceability.
- Standardise Global Submissions: Align with ICH, MDR, and FDA requirements ro reduce review cycles.
- Reduce Time and Costs in Lifecycle Management of Regulatory Documents: Achieve up to 50% faster writing speeds with fewer revisions.
- Improve Data Quality: Minimise manual errors and ensure robust audit readiness for lifecycle management.
The future of regulatory writing
Celegence’s achievement in automating CMC Module 3 document creation with generative AI signals a new era for regulatory operations in life sciences.
As companies face increasing submission volumes and complexity, the ability to rapidly generate, update and maintain compliant documentation will be a key differentiator.