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)
• GMP certification application submission and liasion with EU authority
• GDP audits for warehouses, distributors, and supply chains
• Wholesale Distribution License Applications
• GMP and GDP training
• 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 us