GCP Inspection readiness program



We offer a GCP Inspection readiness
programme consisting of

  • 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