Our Team

Dr. David Lim 

President, CEO and Principal, Regulatory Doctor

Former FDA Employee

David Lim

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Please listen to an audio introduction about Dr. Lim below.

Please watch a video introduction about Dr. David Lim.

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Our team is led by Dr. David Lim (Dr. Lim), a former FDA employee.  Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia.  He discovered a novel growth factor and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke University Medical Center (Duke), California Institute of Technology (Caltech), University of California at Berkeley (UC-Berkeley), US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (Luminex Company). In 2009, he served as a panel member during the FDA’s transparency public meeting. Prior to leading Regulatory Doctor, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals.

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Regulatory Doctor provides Practical, Actionable and Sustainable Solutions in an Integrated, Thorough (PASSIT) manner integrated with emotional intelligence (EQ) skills to the global healthcare industry for all aspects of global regulatory affairs, quality, clinical affairs and compliance matters.

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Dr. Lim has analyzed thousands of FDA warning letters, attended more than 50 FDA advisory panel meetings, and analyzed the subject matters and decision-making processes in detail.  Dr. Lim recently developed FDA inspection checklists for device and drug manufacturers based on the past seven (7) years of 483s issued by the FDA.

As a former patent prosecutor licensed to practice in patent cases before the United States Patent and Trademark Office (USPTO) and also as a regulatory affairs and quality professional, Dr. Lim is familiar with hundreds of 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).

Dr. Lim is regulatory doctor, coach, mentor, FDA consultant, and public speaker for global matters of regulatory affairs, regulatory compliance, quality and clinical affairs. Currently Dr. Lim is an adjunct professor in Regulatory Affairs at Northeastern University.

You can reach him by email or schedule an appointment below.

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