Quality & Compliance
Inspection Readiness & Support
Getting ready for regulatory inspections, and support while they take place.
What's Included
- Mock inspections for FDA, EMA, MHRA, SFDA and other authorities
- Inspection readiness programs and gap assessments
- Storyboards and key-process documentation
- Staff interview training and coaching
- Back-room and front-room support during live inspections
- Responses to Form FDA 483, warning letters and inspection findings
- Post-inspection CAPA follow-up and effectiveness checks
- Sponsor and site inspection readiness