Auditing

OUR HIGHLY EXPERIENCED AUDITING TEAM HELPS SELECT AND SUPERVISE YOUR CONTRACTORS AND SUPPLIERS SO THEY MEET THE REQUIRED QUALITY STANDARDS.

- Dr. Lutz Müller Head of Chemistry, Manufacturing and Controls/Chemist

Auditing

Our in-house auditing team, supported by local regulanet® members, assists in all aspects of auditing and provides the following services:

Third party audits

  • GMP audits for drug substances and products, including investigational medicinal products and supply chains (with special experience in Asia)
  • GDP audits for warehouses, distributors, and supply chains
  • GLP audits for safety, pharmacology, toxicology, and 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 (Mock Audits)

Experienced and frequently trained audit team with local reliable support by our regulanet® members



Have a question concerning Auditing? Contact Dr. Lutz Müller.