Practice Areas
JOSEFINE SOMMER is an experienced EU regulatory and compliance lawyer, advising biotechnology, pharmaceutical and medical device/IVD clients. Her practice encompasses life cycle management, advising innovators, including clinical stage companies, on pre- and post-market regulatory and compliance issues, market access strategies, and interactions with the EU competent authorities.
Josefine advises clients on strategic pathways for marketing authorizations, regulatory data protection and exclusivity rights, and market access. She counsels clients on relevant EMA procedures, including regulatory risks and considerations for novel products, and provides related strategic advice. Building on many years of experience, Josefine helps companies meet EU GxP requirements and counsels on complex issues related to safety, quality and data integrity, supporting inspection readiness and responses. She also advices on advocacy before health authorities.