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

Regulatory Team

Our regulatory team is headed by Beate Kienzler, a Dr. Regenold employee since 2000. Her team is made up of a diverse pool of academics, from regulatory experts, pharmacists, and chemists, to project managers, product information specialists, and software user and logistic groups.

The regulatory team assists in all marketing authorization applications, whether national, MRP, DCP, CP, or those within or outside of Europe, and also provides strategic regulatory 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, Product Information Text Management, PSURs, xEVMPD Data Entry, and renewals.


Team Leader:

Beate Kienzler

Head of Regulatory / Pharmaceutical Technical Assistant

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

Nadja Arndt

Procedure Management & Regulatory Affairs / Trained Administrative Clerk

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

Daniela Dietz

Procedure Management & Regulatory Affairs / Pharmacist for Drug Information

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

Nadine Dörflinger

Procedure Management & Regulatory Affairs / Health Information Manager

Phone: +49 7632 8226-580
Fax: +49 7632 8226-555

Björn Hauck

Procedure Management & Regulatory Affairs / IT Application Specialist

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

Annette Lueg

Procedure Management & Regulatory Affairs / Graduate Engineer

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

Jutta Miekley

Procedure Management & Regulatory Affairs / IT Application Trainer

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

Sonja Rüdele, BA (Hons.)

Procedure Management & Regulatory Affairs / Food and Hygiene Technologist

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

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

Anne-Katrin Vetter

Procedure Management & Regulatory Affairs / Administrative Support

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

Ilias Zontiros

Procedure Management & Regulatory Affairs / MSc, BSc

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