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Auditing

• Third party audits
  • GMP audits for drug substances, drug products including investigational medicinal products and supply chain
  • GDP audits for warehouses and distributors
  • GLP audits for safety pharmacology, toxicology, human and animal bioanalytical studies as well as other studies conducted under GLP
  • GCP audits for CROs, study sites and other vendors including central labs and drug repositories
  • Pharmacovigilance audits
• Vendor qualification audits
• Preparation of inspections
• Experienced and frequently trained audit team with local reliable support by our regulanet® partners