GMP consultation

Our competent GMP consultants support clients in fully complying with good manufacturing practice (GMP), good distribution practice (GDP) and similar guidelines while conserving resources.

Consultants for Good Practices (GxP)

We are experienced GDP and GMP consultants who help pharmaceutical companies when it comes to quality assurance. Our services include:

  • Needs/requirement analysis and GDP / GMP consulting
  • Development and/or adaptation of quality management systems (QMS)
  • Documentation: SOPs, QM manual
  • Planning and carrying out of self-inspections
  • Supply-chain audits and audit coordination
  • Assistance with inspections performed by competent authorities
  • Support in efficiently taking corrective and preventive actions (CAPA)

Audit reports for purchase

We have already performed inspections of active pharmaceutical ingredients from numerous manufacturers around the world to determine whether the APIs are being manufactured in compliance with GMP guidelines. Further information and a list of available API GMP audit reports can be found here >>

Dr. Franz-Josef Kappenberg
Associate Director GxP
Dorothee Klöpf
Associate Director GxP

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