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CoAuthor™

Life Science GenAI Software for Medical Writing

Accelerate regulatory medical writing with Generative AI

Discover how CoAuthor™ can streamline the drafting of regulatory documents directly in Microsoft Word. Combining a life science-specialized GenAI, structured content authoring, and a comprehensive eCTD template library, CoAuthor empowers regulatory writing teams to focus on contextualizing data and developing key messages. With built-in transparency, consistency, and collaboration tools, CoAuthor reduces submission timelines, enabling faster access to life-saving medicines for patients.

Developed by regulatory writers, for regulatory writers, CoAuthor simplifies the complexities of regulatory writing while ensuring safe and secure use of your data behind your organization-specific firewall.

A reg writer’s version of Microsoft Word

CoAuthor is directly integrated with Microsoft Word, extending your favorite writing application.

Consistency within and across study documents

With a permissions-governed repository of structured content, you can be assured that study identifiers, chemical formulas, mechanisms of action, and any other “verbatim” content remains consistent.

Human-at-the-helm AI

CoAuthor’s GPT, built on proprietary retrieval-augmented generation (RAG) architecture, references only the source data and text you allow, ensuring accuracy and direct referencing. Run, rerun, and refine text and data summaries in real-time, knowing that your data and prompts are 100% private to your organization.

There’s a (customizable) template for that

Select from any of more than 280 eCTD templates and customize them with your organization’s standards. Additionally, you can upload your own templates and rest assured that all templates are private in your organization-specific template library.

Flexible Document Control

Upload your source files as .docx, .rtf, or .pdf. Then generate documents such as patient narratives, clinical study reports, protocols, PK/PD reports, and more with ease.

"When you think about the regulatory process from a patient’s perspective, the faster we can get a submission prepared and submitted, the faster that submission gets approved, and the faster patients have access to that medicine or whatever the health care solution is."

Heather Graham
Vice President – Regulatory Writing & Scientific Publications

Book a demo today

Schedule a demo or consultation to see how CoAuthor simplifies the complexities of regulatory writing.

About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.