The FDA Group is a global leader in FDA compliance consulting and regulatory submissions in pharmaceuticals, biotechnology, medical devices/diagnostics, and food.
The FDA Group’s services include:
- Compliance Master Planning and Strategy
- Preparation for Inspections
- Preapproval and Mock FDA Inspections
- Vendor / Supplier Audits
- Clinical Site Audits
- Gap Analysis
- Formal Risk Assessment
- Risk Mitigation Strategies
- Assistance with Regulatory Issues
- Support with 483’s / Warning Letters / Consent Decrees
- Regulatory Advisory Letters (RAL)
- Interim & Permanent Quality & Regulatory VPs, Directors, and Managers
- International Quality & Regulatory Expertise
- Preparation / Assistance with Regulatory Filings
- Quality Systems Guidance and Development
- Corporate SOP Guidance and Development
- Dietary Supplements and Nutraceuticals
- Assistance with Imports
- 21 CFR Part 11 Compliance Strategies
- Validation and Qualification Services
- Training / Development of Training Programs
Why choose us? We command:
- Client satisfaction: Dedicated to understanding and responding to our clients’ needs, providing insight into current industry and regulatory trends and initiatives so as to meet or exceed all client expectations.
- Continuous improvement: Committed to a culture of Total Quality to optimize our service quality, client satisfaction, and client profitability.
- Public responsibility: Committed to honesty, integrity, accountability, and responsibility in all aspects of our work.