regenold GmbH is specialized in pharmaceutical development, regulatory and market access. Founded in 1994, we have helped many clients progress their product developments by providing scientific and regulatory advice, through to gaining regulatory approval and marketing authorization both nationally and internationally.

Our ultimate aim is to help clients maximize the value of their product or device’s life cycle amid a constantly evolving regulatory and market access environment. By developing innovative, tailored, and cost-effective strategies, we help clients achieve milestones in regulatory approval and market access.

In 2001 we founded regulanet® which is a network of independent regulatory consultancies and experts with representation in over 90 countries throughout the world.

The network members offer services to a wide variety of national and international pharmaceutical and healthcare clients, including all aspects of development, regulatory and market access in their respective countries.
For more information please visit: https://www.regulanet.com

In order to service the increasing interest and importance of medical devices, regenold GmbH has a division CE plus, which specializes in international regulatory affairs for medical devices and in vitro diagnostics including combination products, companion diagnostics and medical apps. The core competence of CEplus is CE marking for the European market as well as offering associated activities to assist clients realize market success.

CE plus is linked with regulanet® and therefore able to access resources and manage complex international projects on behalf of clients. For more information please visit: http://www.ceplus.eu



Pharmaceutical

regenold GmbH

Marcel Wöllbrink

Manuel Vögtli

Kaja Neubert

Ilias G. Zontiros

Stacey Weber

Caroline von Spee-Mayer

Pantea Saboor

Nadja Arndt

Karen Schamp

Dr. Manuela Pfeiffer

Christine von der Brelie

The Regulatory Affairs Team at regenold GmbH is responsible for guiding pharmaceutical and healthcare clients through the complex landscape of regulatory approval and market access. They develop innovative and tailored strategies to help clients achieve regulatory milestones for pharmaceuticals, medical devices, in vitro diagnostics, and combination products. The team leverages expertise in clinical product development, compliance, and regulatory management, while coordinating with the regulanet® network to manage international projects and ensure products meet diverse regulatory requirements globally.

Regulatory Affairs Team

Regulatory Affairs Team

About

Team members