European Life Sciences Regulation

The firm’s Amsterdam, Brussels, and London-based life sciences practice focuses on helping clients navigate the complex regulatory laws, policies, and procedures that apply to companies in the pharmaceutical, biotechnology, medical technology, and food sectors. We have unrivalled experience assisting clients in steering applications for authorization of medicinal products through the centralized, decentralized, and mutual recognition systems, and provide guidance on regulatory requirements under the medical devices legislation. We have a particular focus in novel technologies, including gene-and cell-based products, combination products, and companion diagnostics. Our team has a strong track record in assisting clients in responding to GxP audits for medicines and devices; the roll-out of compliance programs; and handling enforcement issues. Clients also routinely turn to us for help in navigating pricing and reimbursement challenges under the complex national payment systems, and to demonstrate the clinical and cost-effectiveness of their products before relevant national administrative bodies.

Our lawyers offer both contentious and non-contentious advice and assist clients to engage successfully with the European and national authorities and other regulatory bodies. When companies need to assert their rights in litigation, we have extensive experience in conducting administrative law proceedings against regulatory agencies in national courts and the European Court of Justice.

In addition to former senior regulators, our team includes lawyers who are qualified in medicine and other scientific disciplines. We have long maintained a network of preferred counsel in other jurisdictions with whom we collaborate on local law issues. Our team collaborates with colleagues across the firm to seamlessly manage cross-border regulatory compliance issues and litigation with global implications.