International and FDA Consulting Services
We believe in overcoming Status Quo – helping industry achieve goals and objectives easier and better.
Practical, Actionable and Sustainable Solutions (PASS).
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.
- We also provide research services to support your due diligence activities (e.g., safety signal detection for medical products – drugs, biologics and medical devices).
Our Consulting Services
- Our consulting services include, but are not limited to, the following on a global basis including DHHS/US FDA, EU (European Commission), Health Canada, Korea MFDS, CFDA, and Therapeutic Goods Administration (TGA), etc.
- Our global and FDA consulting services include, but are not limited to:
- FDA management consulting
- medical devices
- in vitro diagnostics (IVDs) and laboratory developed tests (LDTs)
- premarket notification (PMN or FDA 510(k))
- premarket approval (PMA)
- quality system regulations (QSR) and quality systems
- medical device reporting (MDR)
- corrective and preventive action (CAPA)
- ISO 13485 and 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, and dietary supplements
- FDA (BIMO) inspection, 483s, FDA warning letters, and consent decree (permanent injunction)
- clinical trials, clinical evaluation, risk management, pharmacovigilance, pharmacy compounding, FDA registration and listing, electronic submission to FDA, and 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.
Our Global and FDA Compliance Training Program
The information on this site is being provided for informational purposes only and it should not be interpreted or construed to guarantee to update the information unless indicated otherwise. We do not warrant the accuracy of the information and/or the materials provided herein, either expressly or impliedly, for any purpose and in any way, shape, form or manner.
Last Updated: 2016-06-06