Inspection Readiness
The successful approval of your new product application can be severely impacted by the state of your office, personnel, investigators, manufacturing facilities and laboratories level of Inspection Readiness. We have successfully assisted many of our clients with assuring inspection preparedness. Our Pre-approval preparation efforts focus on:
- New Product Application/Documentation
- Accuracy and Adequacy of supporting documents and procedures
- Personnel (Sponsor, CRO, Investigator, Laboratory) training on inspection process
- Mock inspections