AI-Enabled Regulatory Writing
AI-Enabled Regulatory Writing
Maximize document speed, reproducibility and scientific quality with Certara’s AI-enabled regulatory writing solution
The Right Technology in the Right Hands
Biomedical intelligence is exploding. Studies are growing more complex and the rules for regulatory documents are changing constantly. It takes experts, equipped with the ultimate writing assistant, to deliver the technical accuracy and scientific quality required of your regulatory documents.
Expert Services Across Therapeutic Areas and Document Types
Certara is home to more than 400 MD, PharmD & PhD Drug Development Scientists, Regulatory Writers, and several Centers of Excellence, including Rare Disease and Pediatrics, making our team your best choice for success. Together, they offer a range of tailored medical and regulatory writing capabilities that cover the full drug development continuum.
Certara can help you with:
- CMC and Nonclinical Writing
- Safety and Annual Reports
- Clinical Submission Writing
- Biostatistics and Programming
- Study-level Documentation
- Document Publishing and Quality Control
Experience
>90% of all novel drugs approved by the U.S. FDA since 2014 were supported by Certara services or technology.
Trust
Our regulatory team reached its 300th regulatory submission in 2023.
Technology
Certara’s CoAuthor provides transparency, consistency, and collaboration to allow regulatory writing teams to accelerate the drafting and submission of quality and compliant regulatory documents.
CoAuthor™: The Generative AI-Enabled Regulatory Writing Platform
CoAuthor expedites the writing process by enriching Microsoft Word with three purpose-built capabilities
Generative AI
Leverage a life science specialized GPT behind your firewall for secure, prompt-based text generation. CoAuthor features a proprietary retrieval augmented generation (RAG) based architecture which significantly reduces hallucinations and provides references to source material for simplified QC of documents.
Structured content authoring
Reuse any portion of your writing, from a compound name to complete paragraphs on mechanism of action, across all your documents. Collaborate with your peers on a single source of truth and explanatory style.
eCTD Template Suite
Spend 50% less time formatting your document by applying your style guides to more than 275 eCTD compliant templates.
What can you do with CoAuthor and Certara’s Regulatory Services?
Whether you extend your team with ours or empower them with the right technology, Certara helps you deliver better documents faster.
- Focus on key decision points
- Ensure consistency and quality through standardization
- Reduce time and costs through faster authoring and review
Talk to a Certara Expert Today
Complete the form to book your no-obligation demo of Certara’s AI-enabled regulatory writing platform… and see how better off you could be!
