Thank You and Welcome to Regulatory Doctor!
I, David Lim, am President and Principal of REGULATORY DOCTOR.
We provide unique consulting services in various areas of regulatory affairs, quality, clinical affairs, and regulatory compliance to the global and FDA-regulated industry.
We daily strive to provide you with the Practical, Actionable, and Sustainable Solutions/Strategy in an Integrated, Thorough (PASS-IT) manner, helping you make informed, accurate and best decisions.
Our Service Areas
Our services include, but not limited to, the following on a global basis including US FDA, EU, Health Canada, MFDS (Korea), CFDA, and TGA, etc.
- Food – labeling and quality
- Animal Drugs - approval process, regulatory compliance and quality
- Human Drugs – labeling, advertising and promotion, regulatory documentation/submission, approval process, and cGMP
- Compounding Pharmacy – regulatory compliance and quality (cGMP)
- Cosmetics - labeling and regulatory compliance
- Tobacco Products – regulatory compliance
- Medical Devices including In Vitro Diagnostic Devices
- All global regulatory preparation and submission for pre-submission (Q-submission), IDEs, 510(k)s, FDA advisory committee meeting, PMAs, and petition/appeals, etc.
- Quality (cGMP)
- Clinical evaluation and clinical study/trial design
- Regulatory compliance -
- Affiliate Sales and Marketing – for good quality products
- Promotion and Advertising (NEW): surveillance services on social media for drug and device firms
- Regulatory Compliance Matters: global and FDA inspection preparation and readiness, management, responses to 483s and remediation
- Patent application/filing by a licensed patent practitioner with the US Patent and Trademark Office
- Clinical Trial Design and Data Analysis: clinical trials for drugs, biologics, and medical devices including IVDs
- FDA Advisory Committee Meeting: preparation, logistics, outcomes, and analysis.
- FDA Decision Making Process and Prediction for drugs and medical devices including IVDs.
- Global market trend analysis for medical devices and IVDs, drugs (generics) and healthcare products.
- Adverse event reporting and complaint handling
- Postmarket activities
- Promotion and advertising
- Social media practices
- Medical trends for product design and development
Updated: July 12, 2014