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 interactions with the EU competent authorities.
Life Cycle Management: 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.
Clinical trials and GCP: Building on many years of experience, Josefine supports clinical trials sponsors on good clinical practice (GCP) compliance, including providing strategic advice on complex issues related to safety or data integrity supporting clients in GCP inspection readiness and responses, as well as advocacy before health authorities.
GMP and QMS: Josefine advices on EU GMP and GDP requirements at the clinical and post-approval stages, data integrity responsibilities, and import and export issues. She leverages years of practical experience and interactions with health authorities in advising on practical solutions meeting industry benchmark. She also regularly supports clients in GxP compliance related to the use of AI and other technologies.
M&A: Drawing on her broad life sciences regulatory knowledge, Josefine regularly conducts EU regulatory due diligence for private equity and M&A transactions, making strategic recommendations on areas of potential risk.
Other areas of Josefine’s practice includes:
Combination products, DCx, Devices, AI and Digital Health: Josefine has extensive experience on regulatory compliance with EU medical devices/IVD requirements, including combination products and CDx . She advises clients on applying a practical and business-oriented approach, and she regularly supports companies in responding to safety or compliance-related interactions with health authorities and Notified Bodies. Josefine is also a qualified ISO 13485 (medical devices – quality management system) Medical Devices Lead Auditor. She regularly supports clients in AI regulatory compliance, transactions, and collaborates focusing on AI development and policy.
Food, Cosmetics and Environment: Josefine advises clients on EU food and cosmetics law, in particular novel foods or complex compliance matters. She also advises clients on EU environmental law, including chemicals legislation in relation to the manufacture, import, use – and phasing out – of chemicals in pharmaceutical, biotech and medical devices, and IVDs products.
She is a board member of W@LifeSciences, a reference platform for women professionals working in the life sciences industries and co-founded Sidley’s Women’s Life Sciences Network (WLSN), a highly successful international networking forum that meets regularly to discuss high-level life sciences law and policy developments, and facilitates informal contact for female life sciences regulatory professionals.
Josefine is recognized in Legal 500 EMEA (Belgium) 2024 for EU Regulatory: Pharma, Medical Devices, and Biotech, where clients commented that she is “is a fantastic practitioner. She is extremely competent, but also available at short notice. She provides regulatory but also strategic advice. She, and her team, provide realistic timelines for project completion.”
Josefine also features in “Rising Stars – Life Sciences” of Legal Media Group’s Expert Guides since 2019. In 2022, she has been included in Law.com International’s “Rising Stars: Europe’s Best Up and Coming Female Lawyers” list.