GMP/GDP AUDITING

We provide full-scope Good Manufacturing and Distribution Practice Services to ensure your compliance with the relevant EU and CIS legislation.

We provide consultancy on all aspects of GMP and additional QP-services. This is an external “Qualified Person” (QP) – that is a competent person who carries out the regular work and takes responsibility in accordance with § 14 AMG on a freelance basis.

  • Services of Qualified Person
  • Third Party Service set up for batch release
  • Quality Systems set up and review
  • Writing of SOPs and other documents
  • Auditing
    • Preparations for GMP, GDP audits and inspections
    • Third party GMP audits of API manufacturers
    • GMP inspections arrangement from health authorities
  • Training
  • GMP API audit reports
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We guarantee highly qualified support, deadline compliance, and project control!