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Regulatory/Compliance Services
- Development/Review/Assessment of FDA Submissions (INDA, NDA, ANDA, 510(k), PMA)
- Submission Strategies
- Mock FDA Inspections
- Pre-Approval Inspections
- Quality Systems Benchmarking/Certification Assistance
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Validation Services
- Validation Strategy & Implementation
- Third Party Quality Review & Management
- Project Planning & Management
- Methodology Development (Validation & System Development Life Cycle)
- Validation Master Plan Development
- Project Validation Plan Development
- Protocol Development (IQ/OQ/PQ)
- Protocol Execution
- Validation Summary Report Development
- Support Documentation & Quality Systems
Auditing Services
- Facility & Quality System Audits
- Computer System GAP Analysis
- Part 11 Compliance
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