Consulting
Meet our GxP consultants
Do you need support in establishing, improving or modernizing your QM system?
Pharma-audit helps you to position yourself safely and exceed the expectations of the authorities!
- Creation of documents: SOPs, VMP, GMP room requirements, room qualification templates etc.
- Modernization and updating of the QMS
- Support in the implementation of qualifications and preparation of qualification documentation
- Preliminary risk assessments
- Data Integrity
Our GxP consultants put their many years of experience in the pharmaceutical industry at your disposal!
We are always informed about current trends in the pharmaceutical industry thanks to our geographical and operational proximity to the German Pharmaceutical Industry Association (BPI).
Our audit specialists
Get to know us.
Dr. Dieter Bloß
Head of APM Board
Dr. Bloß holds a doctorate in chemistry and can look back on a long career in the pharmaceutical industry.
At G.Pohl Boskamp, he held positions such as Head of Quality Control, Vice President Scientific Affairs, Senior Director Quality Control and 10 years as a Qualified Person before retiring in 2015.
Today, Dr. Bloß is dedicated to the QM system of the Audit Management business unit at Heacon Service GmbH.
Dr. Bernd Hasken
Head of APM + APM Board Member
Dr. Hasken has successfully managed the audit program since 2015.
As a doctor of chemistry and trained auditor, he co-founded and established the Shared Audit Program and the APM Board in its current form.
In addition to managing the audit program, he also works as an auditor worldwide.
Dr. Marcus Niehörster
APM Board Member
Dr. Niehörster has been working worldwide as an auditor, expert and consultant for authorities and pharmaceutical companies for over 25 years.
He worked for over 20 years as a consultant, auditor and trainer for PCS GmbH in the role of managing director.
He is professionally qualified as a Senior GMP Compliance Expert and as a Senior GMP Auditor and has been a GMP Technical Expert of the Swiss Accreditation Service SAS for 15 years.
