Sidley Austin LLP

Food, Drug and Medical Device

Partner

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, IP regulatory rights, and market access. She counsels clients on relevant EMA procedures, including regulatory risks and considerations for novel products and related strategic advice. Josefine also advises on cross border compliance issues, including advertising and promotion, interactions with HCPs , etc.