Auditing Team

WE SUPPORT YOU IN SELECTING AND SUPERVISING CONTRACTORS AND SUPPLIERS, ALWAYS MEETING THE REQUIRED QUALITY STANDARDS OF THE PHARMACEUTICAL INDUSTRY.

- Dr. Lutz Müller Head of Chemistry, Manufacturing and Controls/Chemist

Auditing Team

Due to our auditing team’s involvement in the overall development of pharmaceutical products, we also offer services in pharmaceutical-related audits. Our team, also coordinated by Dr. Lutz Müller, conducts GMP and GDP audits for drug substances and products, including clinical trial supplies for clinical studies, as well as GLP audits for all required GLP-related areas, including environmental studies. Additionally, Lutz and his team offer third-party audits, which can help clients reduce costs.

Other pre-clinical studies can be audited according to customer requirements. For example, GCP audits can be carried out for all phases of clinical trials, including CROs, study sites, bioanalytical laboratories, and various study documents such as trial master files and external vendors. GVP audits of pharmacovigilance vendors, as well as vendor selection, IMS, and preparatory audits of inspections, can also be performed.


Team Leader:

Dr. rer. nat. Lutz Müller

Head of Chemistry, Manufacturing and Controls/Chemist

Phone: +49 7632 8226-50
Fax: +49 7632 8226-555

Stephanie Atkinson

Senior Expert / MSc Organic Chemistry

Phone: +49 7632 8226-419
Fax: +49 7632 8226-22

Dr. Andrew Leary, MD

Clinical Pharmacologist / Pharmaceutical Physician / Senior Medical Expert

Phone: +49 7632 8226-418
Fax: +49 7632 8226-22

Dr. med. Andrea Niese

Head of Medical & Preclinical / Physician

Phone: +49 7632 8226-405
Fax: +49 7632 8226-22

Dr. rer. nat. Tobias Ostler

Biologist / Authorized Officer / Head of Biologics

Phone: +49 7632/8226-422
Fax: +49 7632/8226-555

Dr. rer. nat. Bruno Rung

Head of Food Supplements & Cosmetics / Food Chemist

Phone: +49 7632/8226-430
Fax: +49 7632/8226-22

Dr. rer. nat. Karen Schamp

Procedure Management & Regulatory Affairs / Pharmacist

Phone: +49 7632 8226-420
Fax: +49 7632 8226-555

Dr. Laurent Schmitt

Procedure Management & Regulatory Affairs / Chemist

Phone: +49 7632 8226-411
Fax: +49 7632 8226-555

Dirk Sorgenfrey, Ph. D.

Senior Expert / Pharmacist

Phone: +49 7632 8226-490
Fax: +49 7632 8226-22

Marcel Wöllbrink

Medical devices, food & cosmetics / Bachelor of Water Science

Phone: +49 7632 8226-450
Fax: +49 7632 8226-22

Dr. rer. nat. Christiane Chène

Senior Scientific Expert / Biologist

Phone: +49 7632 8226-404
Fax: +49 7632 8226-22