Certara Launches Next Generation CoAuthor™ Generative AI Regulatory Writing Software

Core Insights - Certara, Inc. has launched its next-generation CoAuthor regulatory writing software, which integrates generative AI with traditional writing tools to enhance the efficiency of medical writing in drug development [1][3]. Company Overview - Certara is a leader in model-informed drug development, providing biosimulation software and services to accelerate drug discovery and development [5]. - The company serves over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries [5]. Product Features - CoAuthor is designed specifically for medical writers, combining generative AI, document templates, and Microsoft Word integration to streamline the creation of regulatory documents [1][3]. - The platform allows for a "human in the loop" approach, ensuring that medical writers can maintain control over the content while benefiting from AI-generated suggestions [1][4]. - CoAuthor improves the time to first draft by at least 30%, significantly reducing drafting time while enhancing content quality and consistency [4]. Industry Context - Medical writing has remained largely unchanged for the past two decades, relying on manual processes that are increasingly inadequate for the complexities of modern drug development [2]. - The demand for secure, specialized generative AI solutions in life sciences is growing, as companies seek to enhance their regulatory and medical writing capabilities [3].