The FDA Group Consultant’s Core Competencies Include:
- Compliance Master Planning and Strategy
- Preparation for Inspections
- Pre-approval and Mock FDA Inspections
- Vendor / Supplier Audits
- Clinical Site Audits
- Gap Analysis
- Formal Risk Assessment
- Risk Mitigation Strategies
- Support with 483′s / Warning Letters / Consent Decrees
- Interim & Permanent Quality & Regulatory VPs, Directors, and Managers
- International Quality & Regulatory Expertise
- Assistance and Review of Regulatory Filings (IND’s/PMA’s/NDA’s/ANDA’s/BLA’s/510(k)’s/etc.)
- Quality Systems Guidance and Development
- Corporate SOP Guidance and Development
- Mock Product Recalls
- Assistance with Product Recalls
- Process and Utility Design Review and Assessment
- Facility Layout Review and Assessment
- Dietary Supplements and Nutraceuticals
- Assistance with Imports
- 21 CFR Part 11 Compliance Strategies
- Validation Master Plans
- Equipment and Instrumentation Qualification
- Utilities Qualification
- Process Validation
- Cleaning Validation
- Analytical Methods Validation
- IT Qualification and Computer Validation
- Training and Development of Training Programs
