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Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, www.RegulatoryDoctor.com, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides Practical, Actionable and Sustainable/strategic Solutions in an Integrated, Thorough (PASS-IT) manner for all aspects of global regulatory, quality, clinical and compliance matters. Dr. Lim has analyzed over 1,000 FDA warning letters, attended more than 50 FDA Advisory Panel Meetings, and analyzed the subject matters and decision-making processes in detail. He is familiar with more than 200 medical devices, IVD products, biologics, drugs and combination products. Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). In addition, Dr. Lim has completed two years in law school. Dr. Lim is an auditor, regulatory coach, mentor, consultant and instructor for global matters pertaining to regulatory affairs, quality, clinical affairs and compliance.