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.
