Regulatory authorities require companies to audit all suppliers for GMP / GDP compliance. We regularly audit Active Pharmaceutical Ingredient (API) and Investigational Medicinal Product (IMP) manufacturers and comparator suppliers on behalf of our clients.

With experience in the preparation for audits and inspections from various authorities, we can offer guidance and practical support to you in the following areas:

• Site audits of active pharmaceutical ingredients (API) manufacturers
• Site audits of drug product manufacturers
• System and for cause audits
• Supplier and contractor audits
• Pre Regulatory assessment audit and gap analysis
• Mock Regulatory inspections
• Due Diligence auditing of facilities to ensure an appropriate level of due diligence.

GMP compliance auditing of:

• Research and Development Laboratories
• Analytical Development Laboratories
• Chemical and Stability laboratories
• Contract testing facilities