Regulatory Team

WE COLLABORATE WITH OUR PARTNERS TO FIND THE BEST REGULATORY STRATEGY FOR REGISTRATING YOUR PRODUCT.

- Beate Kienzler Head of Regulatory / Pharmaceutical Technical Assistant

The regulatory team is jointly managed by Beate Kienzler and Daniela Dietz

In March 2000 Beate started to work for Dr. Regenold GmbH with a pharmaceutical education background. She learned all her regulatory affairs skills from scratch from doing daily routine work. The routine work at Regenold has the advantage of being wide ranging, involving many procedure types and extremely high numbers of procedures in a short time frame. Over the years she gained a deep knowledge in all regulatory affairs tasks for all types of procedures EU wide but also for non-EU regions. With this longstanding role she extended her position as senior expert and now provides strategic advice and regulatory due dilligence as part of her regulatory repertoire.

The development of the electronic use of documentation in dossiers, followed by the needs for regulatory intelligence is strongly supported and guided by Beate. The current standards at Regenold for eCTD, xEVMPD/IDMP and the automation of processes were developed and implemented by Beate.

Daniela has worked for Dr. Regenold GmbH since 2009. She started her career 1994 in a hospital pharmacy and switched to the pharmaceutical industry in 2001. Daniela held various positions in the pharmaceuticals industry in regulatory affairs, pharmacovigilance (including providing the function of German Graduated Plan Officer and EU-QPPV) and medical information (including providing the function of German Drug Information Officer).

Beate and Daniela are supported by a team of international experts with extensive and longstanding experience in all areas of regulatory affairs. The regulatory team assists in and performs marketing authorization applications and procedures, whether national, MRP, DCP, CP within the European union, as well as outside of Europe. The team provides strategic regulatory advice and support throughout the product's life cycle and development. Additionally, the regulatory team compiles dossier formats (eCTD, NeeS, NtA), CTA, IMPD, IND, and AMNOG, and manages life cycle procedures, including variations, PSURs, renewals and xEVMPD Data collection including xEVMPR. A sub group in the team provides all services related to compilation and maintenance of product Information, packaging material and the regulatory review of promotional material, including supporting or providing the function of the German Drug Information Officer (acc. § 74a AMG).


Team Leader:

Beate Kienzler

Head of Regulatory / Pharmaceutical Technical Assistant

Phone: +49 7632 8226-530
Fax: +49 7632 8226-555

Team Leader:

Daniela Dietz

Head of Regulatory / Pharmacist for Drug Information / Pharmacist for Clinical Pharmacy

Phone: +49 7632 8226-565
Fax: +49 7632 8226-555

Nadja Arndt

Trained Administrative Clerk

Phone: +49 7632 8226-570
Fax: +49 7632 8226-555

Birgit Fiala

Graduate Engineer in Biotechnology

Phone: +49 7632 8226-573
Fax: +49 7632 8226-555

Björn Hauck

IT Application Specialist

Phone: +49 7632 8226-401
Fax: +49 7632 8226-555

Sonja Horvat-Csóti

MSc in Pharmaceutical engineering

Phone: +49 7632 8226-492
Fax: +49 7632 8226-555

Svenja Hutzler

MSc in Pharmaceutical Sciences

Phone: +49 7632 8226-590
Fax: +49 7632 8226-555

Annette Lueg

Graduate Engineer in Pharmaceutical Chemistry

Phone: +49 7632 8226-409
Fax: +49 7632 8226-555

Daria Mari

Pharmacist

Phone: +49 7632 8226-531
Fax: +49 7632 8226-555

Jutta Miekley

IT Application Trainer

Phone: +49 7632 8226-440
Fax: +49 7632 8226-555

Dr. phil. nat. Karen Schamp

Pharmacist

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

Dr. Laurent Schmitt

Chemist, MDRA

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

Rhim Shu

MD, MSc, MPH, Epidemiology & Healtheconomics

Phone: +49 7632 8226-572
Fax: +49 7632 8226-555

Anne-Katrin Vetter

Administrative Support

Phone: +49 7632 8226-460
Fax: +49 7632 8226-555

Ilias Zontiros

MSc, BSc

Phone: +49 7632 8226-270
Fax: +49 7632 8226-555