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Compli provides Regulatory Compliance Consulting Services to all regulated healthcare product industries:
- Pharmaceuticals
- Bulk Pharmaceuticals
- Biotech
- Medical Device and Diagnostic
- Veterinary
- Cosmetics
Services:
- Quality Systems Benchmarking/GAP Analysis
- Quality Systems Auditing (cGMP/GLP/GCP/ISO)
- Quality Systems Development, Implementation and Management
Training
- Regulatory Solutions (483's, Warning Letters, Consent Decree, etc.)
- Development/Review/Assessment of FDA Submissions (INDA, NDA, ANDA, 510(k), PMA)
- Submission Strategies
- FDA Inspection Coordination/Follow-up
- PAI (Pre-approval Inspection) Audits
- CE Mark Consulting
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