Indegene, Inc.

We are the masters of Regulatory Affairs. By bringing process forward depth of competency, a mindset that change is good and best in class outcomes are achievable. We accomplish this by blending the right functional delivery and introduce innovative solutions and advancing agentic AI capability. We have solved complex industry challenges from strategy and consulting through regulatory writing, clinical trial transparency, submissions & publishing management, labelling, and artwork operations. We have demonstrated how solid execution can compress cycle times, ensure faster time to market all without compromising on quality or compliance. 

Visit us at RAPS Convergence to see how two technologies in our Regulatory Automation Suite (Group of NEXT platforms from Indegene for Regulatory Affairs) deliver outcomes 1) NEXT Regulatory Submissions Planning enables faster submissions—along with new capabilities: EU CTR and multi market capacity planning. 2) NEXT Medical Writing Automation is a truly GenAI enabled agentic platform that accelerates authoring through a digital medical writing companion that takes you to the first draft of documents such as aggregate reporting and CSRs. But what next? Next Medical Writing Automation continues as your digital companion to ensure the structure and content of your final product achieves requirements and well-articulated and lean content. Together, our Regulatory Automation Suite and Masters of Regulatory enable regulatory organizations to move faster, operate smarter, and secure approvals with confidence.