Providing International and FDA Consulting Services
By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn)
About the Regulatory Doctor
We are a consulting firm providing consulting services to the global and FDA-regulated industry in areas of regulatory affairs, quality, clinical affairs and regulatory compliance.
Our Consulting Services
Our consulting services include, but are not limited to, the following on a global basis including US FDA, EU (European Commission), Health Canada, Korea MFDS, CFDA, and Therapeutic Goods Administration (TGA), etc.
Our global and FDA consulting services include FDA management consulting, medical devices, in vitro diagnostics (IVDs), laboratory developed tests (LDTs), premarket notification (PMN or FDA 510(k)), premarket approval (PMA), quality system regulations (QSR), quality systems, medical device reporting (MDR), corrective and preventive action (CAPA), ISO 13485, ISO 14971, EU medical device directive (MDD), active implantable medical device directive (AIMDD), in vitro diagnostic medical device directive (IVD(M)D), CE mark, biologics, biosimilars, food, drugs (human and animals), cosmetics, combination products, dietary supplements, eCTD, FDA (BIMO) inspection, 483s, FDA warning letters, consent decree (permanent injunction), clinical trials, clinical evaluation, risk management, pharmacovigilance, pharmacy compounding, FDA registration and listing, electronic submission to FDA, structured product labeling (SPL), labeling, research and proposal, etc.
We also provide global and FDA training seminars in various areas of international regulatory affairs, quality, clinical affairs and regulatory compliance through our educational forum at global compliance seminar.
About Our Consulting Services (Video)
Our Global and FDA Compliance Training Program
Last Date Updated: December 18, 2014