Our Speakers

Dr. David Lim, Ph.D., is a highly experienced ex-FDA regulatory expert with over 20 years of experience across pharmaceuticals, medical devices, IVDs, and biotechnology. As the President and Principal of Regulatory Doctor, he provides strategic consulting in global regulatory affairs, quality compliance, and clinical strategy—particularly in AI-driven regulatory intelligence and GMP compliance. Dr. Lim holds a Ph.D. in Biological Sciences from the University of Missouri-Columbia and has advanced training from Caltech, Duke University, UC Berkeley, and the FDA. He has led hundreds of FDA consulting projects, including Pre-Submission, 510(k), PMA, IDE/IND, and De Novo submissions. Recognized as a pioneer in AI-based GMP compliance and regulatory intelligence, Dr. Lim helps companies integrate AI into regulatory and quality systems while maintaining compliance with global standards such as FDA, EMA, and ISO. A frequent speaker and thought leader, Dr. Lim actively contributes to industry discussions on regulatory policy and AI innovation. He is also passionate about training the next generation of regulatory professionals through workshops, publications, and his YouTube channel, “Medical and Health Tips” (@Medical-HealthTips).