AI in Regulatory Submissions

Getting a product approved in the life sciences industry is no easy feat. It’s a highly regulated space where every submission goes through intense scrutiny. Along the way, Health Authorities (HAs) often come back with questions—requests for more data, clarifications, or additional documentation. And let’s be honest, these queries can be a real headache. If they’re not handled quickly and accurately, they can stall approvals, create compliance risks, and drive up costs.