Team QM Systems, Licenses & Compliance

WE ESTABLISH AND MAINTAIN TAILOR-MADE QUALITY MANAGEMENT SYSTEMS SUITED TO YOUR NEEDS, SUPPORT YOU WITH YOUR EU ESTABLISHMENT AND HELP YOU WITH SELECTION AND SUPERVISION OF YOUR CONTRACTORS AND SUPPLIERS

- Sonja Rüdele Head if QM Systems, Licenses & Compliance / Food and Hygiene Technologist

Team QM Systems, Licenses & Compliance

The team QM Systems, Licenses & Compliance is led by Sonja Rüdele who joint Dr. Regenold GmbH in 2001 as regulatory affairs quality management manager.

Sonja and her team, involving local expertise where necessary, support you with any service that will benefit your existing or intended system, be it for gaining a wholesaler or import license, establishing a system according to DIN ISO 900x, DIN ISO 13485 or fulfilling GMP requirements. They also support you with third party audits, vendor qualification audits and mock inspections.


Team Leader:

Sonja Rüdele, BA (Hons.)

Head of QM Systems, Licenses & Compliance / Food and Hygiene Technologist

Phone: +49 7632 8226-510
Fax: +49 7632 8226-555

Beate Zuther-Schlichtling

QM Systems, Licenses & Compliance / Biologist

Phone: +49 7632 8226-511
Fax: +49 7632 8226-555

Audit experts

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. rer. nat. Christiane Chène

Senior Scientific Expert / Biologist

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

Julijana Dukanovic

Scientific Expert / Pharmacist / Epidemiologist

Phone: +49 7632 8226-416
Fax: +49 7632 8226-22

Vanessa Hyde

Senior Scientific Expert / Auditor / Biologist

Phone: +49 7632 8226-428
Fax: +49 7632 8226-22

Dr. Andrew Leary, MD

Senior Medical Expert / Pharmaceutical Physician / Clinical Pharmacologist

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. 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