• Regulatory Affairs
  • Regulatory services

Regulatory services

We support you with the development, marketing authorisation and life cycle management of your medicinal products, as well as with the classification, evaluation and certification of your medical devices, combination products and in vitro diagnostics.

With our many years of expertise in

we can advise you on strategic issues and demarcation issues, conduct gap analyses and regulatory evaluations and create the necessary reports and documentation. We can guide you through the various phases of development efficiently and successfully, supporting you in the implementation of regulatory requirements in a steadily changing environment.

Dr. Verena Peter
Quality/CMC

Phone: +49 89 2000203-71
Email:

Dr. Christian Schübel
Clinical Affairs/Medical Devices

Phone: +49 89 2000203-52
Email:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0