Regulatory Consulting Services to the Global and FDA-Regulated Industry
Helping Organizations, Groups and Teams Overcome Status Quo is Our Priority for Excellence in Performance and Outcomes!
We Provide Practical, Actionable and Sustainable Solutions (PASS).
About the Regulatory Doctor
- We are a global regulatory 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 Regulatory and Quality Consulting Services
- Our regulatory 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 regulatory and FDA consulting services include, but are not limited to:
- Management FDA regulatory and GMP consulting for FDA matters
- 510k preparation and 510k submission for medical devices including in vitro diagnostics (IVDs)
- Laboratory developed tests (LDTs)
- Premarket notification 510k training for 510k submission for medical devices and IVDs
- Premarket approval (PMA) training
- Quality system regulations (QSR), CGMP for medical devices
- CGMP for pharmaceutical drug industry
- Medical device reporting (MDR)
- Corrective and preventive action (CAPA)
- CGMP for biologics, biosimilars, food, drugs (human and animals), cosmetics, combination products, and dietary supplements
- Mock FDA audit in preparation for FDA inspection and CE mark auditing in reference to CGMP for FDA inspection, 483s, FDA warning letters, and consent decree (permanent injunction)
- Guidance for clinical trials, clinical evaluation
- Risk management and pharmacovigilance
- Regulatory guidance for pharmacy compounding
- FDA registration and listing
- Electronic submission to FDA, and structured product labeling (SPL), labeling, research and proposal, etc.
- ISO 13485 and ISO 14971
- EU medical device directive (MDD)
- Active implantable medical device directive (AIMDD)
- In vitro diagnostic (IVD) medical device directive (IVD(M)D)
- CE mark, Audit, and CGMP
We also provide global and FDA regulatory training seminars in various areas of international regulatory affairs, quality (GMP), clinical affairs and regulatory compliance through our educational forum at global compliance seminar.
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: 2016-10-21