Ranked in 1 Practice Areas
U

Up and Coming

Life Sciences: EU

Belgium

1 Years Ranked

About

Provided by Josefine Sommer

Europe

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.

Chambers Review

Provided by Chambers

Chambers European Guide

Life Sciences: EU - Belgium

U
Up and Coming
Individual Editorial

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.

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