Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is
President and Principal of Regulatory Doctor (www.RegulatoryDoctor.US). Dr. Lim frequently presents global regulatory and
quality compliance topics at Global Compliance Seminar and in various forums and meetings. Recently,
Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA
policy. In addition, Dr. Lim developed FDA inspection checklists for drug and
medical device manufacturers based on his analysis of FDA inspectional
observations cited in 483s for the past seven years. Dr. Lim provides his
feedback to regulatory agency (e.g., US FDA) through public comments and also
served as a panel member during the FDA’s transparency public meeting in
2009. Dr. Lim contributes to the Regulatory Affairs Professional Society
(RAPS) as an author and speaker. Dr. Lim leads and directs all research
projects including pharmacovigilance, medical device reporting, recalls and
patient safety signals being conducted at the Regulatory Doctor. Dr. Lim
serves as a member of the Advisory Board for Inspection Insider published by
FDA News.
Dr.David Lim provides regulatory consulting services
for medical products regulated by the US FDA, an Agency under the US Department
of Health and Human Services (DHHS).
