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Consulting

Meet our GxP consultants.

Meet our GxP consultants

Do you need support with the establishment, improvement or modernisation of your QM system? Pharma-audit helps you to position yourself securely and to exceed the expectations of the authorities.

Consulting
  • Preparation of documents: SOPs, VMP, GMP room requirements, room qualification templates, etc.
  • Modernisation and updating of the QMS
  • Support with the performance of qualifications and preparation of the qualification documentation
  • Preliminary risk assessments
  • Data integrity

Our GxP consultants make their many years of experience in the pharmaceutical industry available to you. We are always informed about current trends in the pharmaceutical industry through our physical and operational proximity to the German Association of the Pharmaceutical Industry (BPI) e.V.

Our audit specialists

Get to know us

Dr. Dieter Bloß

Head of APM Board

Dr. Bloß is a doctoral chemist and can look back on a long career in the pharmaceutical mid-market sector. At G. Pohl Boskamp he held positions including Head of Quality Control, Vice President Scientific Affairs, Senior Director Quality Control as well as 10 years as a Qualified Person, until he retired in 2015. Today Dr. Bloß devotes himself to the QM system of the Audit Management business unit of Heacon Service GmbH.

Dr. Bernd Hasken

Head of APM + APM Board member

Dr. Hasken has been successfully leading the audit programme since 2015. As a doctoral chemist and trained auditor, he co-founded and established the shared audit programme and the APM Board in their current form. In addition to managing the audit programme, he works worldwide as an auditor.

Dr. Marcus Niehörster

APM Board member

Dr. Niehörster has been working worldwide for more than 25 years as an auditor, expert assessor and consultant for authorities and pharmaceutical companies. For over 20 years he worked as a consultant, auditor and trainer at PCS GmbH in the role of a managing director. He is qualified as a Senior GMP Compliance Expert and as a Senior GMP Auditor and has served for 15 years as a GMP expert of the Swiss Accreditation Service SAS.

Request your next audit

Send us your enquiry – we will get back to you promptly with a tailored proposal.