Spiros Drosos is a seasoned life sciences regulatory lawyer with deep expertise in EU pharmaceutical law and litigation. He draws on extensive experience as the former Head of Litigation at the European Medicines Agency (EMA)—where he led the Agency’s representation before the Court of Justice of the European Union (CJEU)—to advise and represent clients in the pharmaceutical, biotechnology, and medical device sectors in regulatory strategy, compliance matters, and litigation, leveraging his insider perspective to provide strategic, practical solutions.

Over his ten-year tenure at EMA, Spiros oversaw legal support to all of its Scientific Committees, advising on complex regulatory and procedural issues. Notably, he served as the exclusive legal advisor to the Committee for Orphan Medicinal Products, guiding its assessments through the legal framework governing orphan designation, incentives, and market exclusivity.

His regulatory counsel is informed by litigation considerations. Spiros has been involved in more than 30 proceedings before the CJEU, including landmark cases concerning data exclusivity, the granting and withdrawal of approvals, orphan drug designation, pharmacovigilance, clinical trial transparency and access to documents, and the procedural rights of regulated companies.

In addition, Spiros contributed to the development of EU pharmaceutical law and policy, providing input on key legislative initiatives and regulatory reforms.

He now applies his combined regulatory, litigation, and policy experience to help life sciences clients navigate the entire lifecycle of medicinal products and medical devices—from early-stage clinical development and marketing authorization to post-approval compliance, safety monitoring, and enforcement.