Biography:

Dr. David Lim is a seasoned ex-FDA regulatory expert with over 20 years of experience in pharmaceuticals, medical devices, in vitro diagnostics (IVDs), and biotechnology. As the President and Principal of Regulatory Doctor, he provides strategic guidance on global regulatory affairs, quality compliance, and clinical strategies.

With a strong scientific background, including a Ph.D. in biological sciences from the University of Missouri-Columbia and advanced training from esteemed institutions such as Caltech, Duke University, UC Berkeley and FDA, Dr. Lim has successfully led hundreds of FDA consulting projects, including Pre-Submission, 510(k), PMA, IDE/IND, and De Novo submissions. His significant expertise in 510(k) training, preparation, and submission has enabled numerous clients to navigate the complex regulatory landscape effectively.

A former Fellow Consultant at the FDA, Dr. Lim has played a crucial role in regulatory strategy and compliance for numerous entities. He is a frequent speaker and actively contributes to industry discussions on compliance and FDA policies. Passionate about education, he mentors regulatory professionals and shares his expertise through training programs, professional publications, and his YouTube channel, "Medical and Health Tips” @Medical-HealthTips.