GCP Inspection readiness program

Gap analysis of IMP development programs, including all clinical trials

Audit of sponsor's oversight (operational and quality management)  

TMFs review and compliance check 

Pre-inspection training program for sponsor's teams and sites

Mock-inspection

Corrective actions support

Sponsor or site inspections coordination

Hosting of Inspection 

Dedicated programs for FDA, EMA, BfArM and Polish GCP Inspection