Compliance
- Due Diligences of Product’s Dossiers / Documentation
- Prepare for facility inspection (AEMPS, EMA, FDA, ANVISA, PMDA, MFDS):
- Pre-inspection preparation audits
- Initial or subsequent Regulatory inspections
- Provide onsite, real-time support during regulatory inspections
- Implement corrective actions and remediation:
- Prepare responses to regulatory agencies observations
- Prepare remediation and subsequent responses.
Compliance is widely-accepted as the best way to conduct business, putting product quality first:
- On-company training plans
- GAP Analysis
- Remediation plans
- Inspection readiness