Certara Launches Next Generation CoAuthor™ Generative AI Regulatory Writing Software

Certara, Inc., a leading figure in model-informed drug development, has launched CoAuthor, a sophisticated regulatory writing programme designed specifically for medical writers. This cutting-edge platform combines generative AI capabilities with document templates, Microsoft Word capability, and tools for organised content creation.

The introduction of CoAuthor represents a huge step forward in medical writing, an important component of drug development that has previously depended on traditional, manual techniques that have remained mostly unaltered over the last two decades. As medication development increasingly includes precision medicine therapies based on complex scientific discoveries, there is a growing need for more efficient data synthesis and presentation methods.

“Life Sciences companies are seeking secure, AI-driven solutions tailored to the nuances of drug development,” stated William Feehery, Ph.D., CEO of Certara. “Certara possesses the technical prowess and scientific acumen needed to harness the full potential of generative AI in regulatory and medical writing.”

CoAuthor, created by and for medical writers, offers simplicity of use with specialised AI models tailored to life sciences, solid client-specific GPT integration, and full eCTD regulatory writing templates. This interface enables medical writers to expedite their drafting process, freeing up time for content curation, collaboration, and quality control initiatives. CoAuthor works easily with Microsoft Word, keeping familiarity while improving uniformity and quality among writing teams.

Christopher Bouton, Ph.D., Senior Vice President of Artificial Intelligence at Certara, emphasized the collaborative approach underlying CoAuthor’s development: “Working closely with our seasoned team of medical writers, we’ve created a next-generation tool that fully leverages the potential of generative AI. CoAuthor enables the creation of consistent, reproducible content, reducing time to first draft by at least 30% through our human-in-the-loop model.”

Certara clients will benefit from the ability to integrate CoAuthor into a full regulatory authoring solution, ranging from program-level efforts to enterprise-wide applications. Certara has partnered with China’s Cloudscientific to provide life science-specific GPTs for drug development, early discovery, clinical trials, and regulatory filing.