Pharmaceutical and Medical Device Law

The regulation of medicinal products for human and veterinary use, as well as medical devices (e.g. prosthetics, dental products, visual aids, laboratory diagnostics, etc.), is largely harmonized at the European level. Specific rules govern the classification, preparation, authorization, registration, labelling, advertising, quality, distribution, and monitoring of such products. A vast number of laws and administrative regulations exist regarding product quality and safety requirements, as well as the rules governing their marketing and promotion.

To avoid sanctions and the resulting corporate liability (or at least to mitigate such risks) companies operating in the pharmaceutical and medical device sectors must ensure full compliance with these regulations. This includes constant monitoring by qualified experts and the implementation of internal compliance rules and procedures.

With a team of specialized lawyers, our firm provides legal advice and support to both domestic and international companies operating in the pharmaceutical and medical device industries (even beyond national borders) covering legal issues throughout the entire product lifecycle, from development and manufacturing to commercialization.

Our legal services include regulatory advice on products, including recommendations for organizing effective compliance systems in the pharmaceutical and medical device fields, representation before national and European authorities and institutions, defense in criminal and administrative proceedings, litigation, as well as issues related to competition law and intellectual property rights. We place particular emphasis on the interdisciplinary nature of this sector.

When needed, we rely on our established network of scientific experts to assess and evaluate complex matters from both a legal and technical-scientific perspective, integrating their input into our legal advice.

Pharmaceutical and medical device law is heavily influenced by European and international regulation. In this context, we combine our global experience, deep knowledge of EU and international law, and comparative law expertise to develop innovative legal solutions for our clients.

Our comprehensive legal advisory services in pharmaceutical and medical device law include: