Up and Coming
Provided by Josefine Sommer
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.
Provided by Chambers
Josefine Sommer operates a varied practice in the life sciences sector, with experience in clinical trials, market authorisations and disputes. She boasts particular skill advising on compliance with EU regulations. Her client list comprises global pharmaceutical companies and medical manufacturers.
Provided by Chambers
I trust Josefine Sommer a lot.
Josefine Sommer has strong flexibility, patience and is very diligent in getting good results.
Josefine Sommer provides very strong support. I can always count on her to respond quickly and to find what I need.
I trust Josefine Sommer a lot.
Josefine Sommer has strong flexibility, patience and is very diligent in getting good results.
Josefine Sommer provides very strong support. I can always count on her to respond quickly and to find what I need.