DDReg Pharma: AI-Powered Regulatory Submissions – A New Era for IND, NDA, & BLA Documentation
The post highlights how AI-driven solutions, developed with a deep understanding of regulatory nuances, are moving beyond the limitations of the traditional electronic Common Technical Document (eCTD) to create a more efficient, accurate, and scalable process. DDReg Pharma showcases how AI is not merely automating tasks but is a powerful tool for time reduction (with potential 30-40% savings in compilation), error reduction through natural language processing (NLP), and ensuring global compliance by adapting to regional regulations.