CoAuthor

CoAuthor™ is Certara's purpose-built Generative AI software for regulatory and medical writing, designed to streamline and accelerate the drafting of complex regulatory documents. By combining a life science-specialized biomedical GPT, a comprehensive eCTD template library, and structured content authoring — all integrated directly into Microsoft Word — CoAuthor empowers regulatory writing teams to spend less time on routine drafting and more time contextualizing data and developing key messages.

CoAuthor is built for regulatory writing teams across biotech, large pharma, and CROs who need to reduce submission timelines, maintain document consistency, and ensure data security throughout the writing process. Developed by writers, for writers, the platform delivers measurable efficiency gains: individual writers report a 2.25x efficiency gain when drafting content, a 40% productivity increase for drafting and quality-checking document sections, and greater than 90% accuracy in automated analysis and summarization of tables, listings, and figures (TLFs).

Core Capabilities

• Purpose-built biomedical GPT integrated directly into Microsoft Word, enabling AI-assisted drafting without leaving your preferred writing environment
• A library of more than 275 eCTD templates available at the point of authoring
• Structured content authoring to support content reuse and ensure consistency within and across study documents
• One-click summarization of text and data, including automated analysis of tables, listings, and figures
• Automated formatting, hyperlinking, and metadata population to reduce manual effort
• Generation of key document types including patient narratives, clinical study reports (CSRs), and protocols
• An off-the-shelf prompt library tailored to regulatory writing tasks
• Real-time preview of document output during authoring

Consistency and Quality Assurance

• A permissions-governed repository of structured content ensures that study identifiers, chemical formulas, mechanisms of action, and other verbatim content remain consistent within and across documents
• Built-in traceability and version control to support document governance and audit readiness
• Integrated quality control review tools that contribute to meeting submission timeline goals
• Transparency and consistency tools that enhance overall document quality and reduce the risk of errors

Collaboration and Workflow Features

• Real-time collaborative authoring and review, enabling multiple writers to work simultaneously
• A metadata and document repository for organized storage and retrieval of regulatory documents
• A regulatory document repository to centralize and manage submission-ready content
• Tech-enabled medical writing services to complement the software platform

Security and Compliance

• Organization-specific, secure AI deployment that eliminates data leakage risks associated with general-purpose AI tools
• Full compliance with global data protection standards
• Certara holds ISO 27001 certification for its Information Security Management System (ISMS), underpinned by robust security controls and continuous risk assessment

Integration and Partnerships

• Seamless integration with Veeva RIM as a Veeva AI Partner, simplifying digital data flows and accelerating regulatory submissions
• Native Microsoft Word integration, extending the familiar writing environment rather than replacing it

CoAuthor is backed by Certara's deep regulatory expertise and is supported by a team ready to partner with organizations on staff training and onboarding. By reducing the time required to produce first drafts and enabling faster quality control reviews, CoAuthor helps life science organizations accelerate regulatory submissions and ultimately bring medicines to patients more quickly.