Enhancing CMC/Module 3 Documentation with Gen AI Whitepaper
Transforming Regulatory Processes Through Artificial Intelligence
Pharmaceutical companies are under increasing pressure to produce structured, high-quality Chemistry, Manufacturing, and Controls (CMC) documentation often under tight timelines. Manual authoring of CMC/Module 3 content remains a bottleneck due to the sheer volume, complexity, and regulatory scrutiny involved.
Celegence’s latest whitepaper explores how Generative AI is reshaping regulatory writing. Leveraging CAPTIS®, our proprietary AI-enabled platform, we partnered with Kenvue to automate the drafting of high-volume CMC documents. The outcome? Drafting time was reduced from hours to minutes—with over 80% alignment to Health Authority submissions following a single round of refinement.
What You’ll Learn from This Whitepaper:
- The potential of Gen AI in regulatory writing workflows
- Real-world outcomes from our AI pilot project with Kenvue
- Which Module 3 sections are most viable for automation
- How to overcome limitations of large language models in compliance settings
- Why human insight remains indispensable in technical authoring
Download the Whitepaper
This whitepaper serves as a guide for regulatory, CMC, and digital innovation teams looking to integrate AI in their authoring workflows. Whether you’re seeking faster submissions, improved consistency, or scalability across regions, the insights in this paper are designed to help.
Download the whitepaper now and take the first step toward transforming your regulatory submissions.
For further regulatory assistance or queries on how Celegence can support your organization, reach out to info@celegence.com today.
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