SERVICES | SUPPORT

Regulatory Authority
Inspections

Based on extensive experience with FDA and EMA regulatory authority inspections.

CQC offers the full range of support:

  • Preparation, facilitation and follow-up of investigator or sponsor/CRO related GCP inspections, e.g. by FDA, EMA or local authorities
  • Conduct of mock inspections and development of CAPA plans
  • Tailored assessment and improvement programs following inspections
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