INSPECTION PREPARATION AND HANDLING

We have extensive experience in the preparation, handling and CAPA resolution of Competent Authority Inspections. The inspections were hosted at the Sponsor, Investigator Site and Vendor. The inspectors were from a wide variety of Competent Authorities, which includes FDA (USA), EMA (EU), MHRA (UK), IGZ (NL), DKMA (D), ANSM (FR), AGES (A), SÚKL (CZ) and PMDA (J).