Services Offered
- Quality System Assessment (FDA 6 System)
- Gap Analysis- FDA 6 System
- Response to Regulatory Inspectional Observations
- Remedial action to Regulatory Inspectional Observations
- Screening of Data Integrity breach and its remediation
- Establishment of Quality Management System Documentation
- Development of Biomonitoring / Microbiological Monitoring Program
- Sterility and Microbiological Assessment
- Aseptic Manufacturing Oversight
(including Media Fill and smoke study) - Support in failure investigation
- Vendor / Supplier Qualification
- Due Diligence Audit
- Mock Audit
- Technical Training
- Tailored Quality System Assessment
