Pharmaceutical Law

We advise pharmaceutical companies on all legal issues connected with the regulatory classification of a product as a pharmaceutical (in comparison to medical devices, cosmetics and dietary supplements, for example), on national and European approval procedures, on the renewal of approvals as well as variations and extensions to them and on regulatory data and market exclusivity.

This includes experienced consulting in the fields of paediatric regulation, orphan drug regulation and advanced therapies regulation. In the course of these activities we frequently act on behalf of our clients before national and European regulatory authorities and bodies, assist with their corporate in-house coordination and planning, and assert the rights of our clients before the appropriate courts. Another of our law firm’s focal points is the safety of pharmaceuticals (pharmacovigilance).

In connection with this, we assist with the implementation of, and compliance with, the strict national and European standards by ensuring that correct and functional corporate in-house processes and decision-making bodies are in place. We also provide support during the preparation stage and offer guidance within the framework of official inspections as well as referral and step-by-step planning procedures. This also includes liability issues under civil and criminal law. At the interface to benefit assessment and the reimbursement of costs, we work hand in hand with other experienced law firms.