As biopharmaceutical companies face mounting pressure to accelerate development timelines and improve the speed and quality of regulatory submissions, many are actively exploring the potential of generative artificial intelligence (GenAI) to transform how regulatory work gets done. This article examines how leading organizations are beginning to apply GenAI to automate content creation, analyse complex data and streamline core regulatory activities — and the critical success factors for driving adoption at scale.
- Jon Williams
- Donna Boyce
- Myrto Lee
