Celegence Pioneers Industry-First Automation of CMC Module 3 Document Creation with Generative AI

Chicago, IL – July 15, 2025 – Celegence, a global leader in regulatory services and technology solutions for the life sciences industry, today announced a landmark achievement: Celegence’s proprietary CAPTIS^® platform is the first medical and technical writing solution to successfully automate the creation of CMC (Chemistry, Manufacturing, and Controls) Module 3 documents using generative AI. 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 six-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 labor-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® standardized 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 organizing 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-standardized documents from CMOs, clinical sites, and R&D teams.
• Compliance and Regulatory Risk: Increasing demands from authorities like 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.
• Standardize Global Submissions: Align with ICH, MDR, and FDA requirements, reducing 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: Minimize 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.

About Celegence

Celegence, creator of the CAPTIS® AI platform, provides a comprehensive range of tech-empowered regulatory affairs services for pharmaceutical, medical device, and IVD manufacturers seeking to balance the quality, timelines, and cost of their regulatory compliance. Celegence leverages Dossplorer™, their proprietary advanced eCTD viewer, to improve efficiency in managing submissions and document review. With extensive delivery capabilities and industry expertise, Celegence helps regulatory and quality teams reduce costs and enhance compliance in a dynamic regulatory environment. Headquartered in the United States, Celegence has offices in Europe and India.

For more updates, follow Celegence on LinkedIn or learn more at Celegence.com.

For more information, please contact:
Rachel Hollos
Marketing Director
Celegence
rhollos@celegence.com