Quality Assurance
- Implementation of a Quality Management System (QMS) + guidance through inspection
- cGxP audits
- Pre-approval inspection preparation at sites
- Mock inspections (FDA / EMA)
- Release of investigational product
- Release of commercial product batches
- Standard Operating Procedure (SOP) writing
- ISO certification management (9001, 13485)
- CAPA management FDA483 resolution
- Monitoring and co-monitoring visits
- For-cause audits
- Warning Letter remediation