About Us
GMP Quality and Compliance Services
- CFR211 and 820 Compliance
- Internal, Supplier, and Third-Party Auditing
Drug / Device Combination Products
- Design Control - User requirements, Design Verification and Validation, Design Review
- Risk Management - Risk Management Plans, Hazard Analysis, FMEA's, FTA's, and Risk Mitigation
Quality Assurance
- Deviation and Complaint Investigations
- CAPA
- Analytical, Equipment and Computer Qualification
- Batch Records