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. Andrea Klüting
Vigilance & Regulatory Affairs
Business Development HWI group
Phone: +49 89 2000203-60
Email: a.klueting@hwi-group.de