Support in handling regulatory authority inspections (before, during and after).
Do you expect an inspection by your supervisory authority? Or do you have an upcoming or recently filed marketing authorization application, and thus expect an inspection by a regulatory authority? Maybe an inspection was already announced? We can provide:
- Intense training workshops for potentially involved personnel
- Check of documents (Trial Master Files, Investigator Site Files, other) for completeness
- Preparation Visits at (potential) inspection sites (investigator or service provider sites, if necessary)
- Support during the inspection, either as facilitator or observer in the front room or as coordinator in the backroom
- Review of the Inspection Report and support in identifying the CAPAs as well as with response drafting