David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA

Helping FDA-Regulated Global Industry Improve Awareness by Providing Compliance Training and Seminars to the Global and FDA-Regulated Industry 

Areas of Compliance Training and Seminars

    • Regulatory Affairs
    • Quality
    • Clinical Affairs
    • Regulatory Compliance
    • cGMP Compliance Matters
FDA Consultant

FDA Consultant

Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. 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 twelve (12) years.

Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributed to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

Last Updated: 2020-07-03