Third Party Audits

Choose PQE as your ideal partner for both routine and due diligence audits.

Based on recent developments in pharmaceutical regulations, concerning starting materials and suppliers, Medical Device Regulations, Suppliers Qualification, Auditing has become even more critical from the GxP perspective. Furthermore, EU and FDA regulators have emphasized that Third Party Audits are accepted. By utilizing its experience in the Life Science sector, PQE supports Pharmaceutical and Medical Devices manufacturers in performing many kinds of audits, conducted worldwide by our lead auditors that have a minimum of 15 years of field experience. Our ISO certified quality system involves a thorough auditor qualification process and an extensive skill matrix methodology which has been successfully implemented by many of top 50 corporations around the world.

Pharma Capabilities
  • Manufacturers of API, Excipients and Intermediates
  • CMO for FDF Biosimilars Manufacturers Distributors & Logistic Operator Contract Laboratories /GMP/GLP) CROs
  • Due diligence Audit for GxP Compliance IT Systems and Business Plan Challenging
  • Software Suppliers
  • Clinical & Pre-Clinic Audits
  • Investigational Site Audit
  • Sterilisation Facilities
  • Suppliers of Equipment & Utilities
  • Pharmacovigilance & Safety Issues
Medical Devices Capabilities
  • Molds Suppliers
  • Process Equipment & Utilities Suppliers
  • Raw Materials Manufacturers
  • Components and semi-finished parts Manufacturers
  • OEM Manufacturers
  • Contract Manufacturing Organizations
  • Contract Testing Laboratories
  • Sterilisation Facilities
  • Distributors and Logistic Providers
  • Software Application Suppliers (PDA And Tick-it Certified Auditors)
  • Clinical Trials Centers
  • Due Diligence (Quality) of Product and Facility Acquisitions