Indegene Unveils GenAI Automation Platform to Revolutionize Clinical and Regulatory Documentation

Published: 14 Jul 2025

Author: Precedence Research

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Indegene, a global leader in digital-led commercialization for the life sciences industry, has announced the release of a breakthrough platform to automate and optimize the process of generating high-quality, regulatory-compliant documents. Bringing over 30 years of experience in medical writing with the latest generative AI (GenAI). This new tool addresses an important problem in clinical development, regulatory submission, and medical affairs, where life sciences companies struggle to keep up with the rising demands for documentation of the correct quality and velocity.

NEXT Medical Writing Automation is created by experienced medical writers and runs on Indegene's proprietary artificial intelligence engine, Cortex. This has been developed with an in-depth appreciation of challenges faced in the industry, scattered data, and constantly changing regulatory guidelines. The platform combines domain-specific intelligence with multi-agent orchestration and advanced knowledge engineering, all delivered over a secure, enterprise-grade system. It has also been intentionally designed to run smoothly with other well-known applications, such as Microsoft Word. Any medical writing team can use them to create regulatory-ready drafts that automatically convert into layouts and compliance guidelines specific to the sponsor company.

Indegene launches an innovation at the right moment in the life sciences industry. Clinical trials and drug development have become increasingly complex, with data becoming larger, more regulations involved, and submissions expanding to a wider global Scale. Such pressures make medical writing teams the focal point of strategic work, as they create submissions-ready documents that are also scientifically rigorous, traceable, and conform to international standards. NEXT Medical Writing Automation is poised to become a game-changer, offering a smart solution that reduces the human workload, ensures consistency, and enables shorter go-to-market cycles for life-saving treatments.

NEXT Medical Writing Automation focuses on an overall vision of Indegene, which is capturing the initiative in driving digital transformation throughout the life sciences value chain. The company partners with various biopharmaceutical, biotech, and medical device companies in the areas of clinical development, regulatory activities, pharmacovigilance, and commercialization. Indegene can transform these organizations by embedding AI in their time-honored manual processes, enabling them to work more efficiently, be scalable and resilient, and respond more effectively to market pressures and the need for faster innovation.