Geneviève Michaux

Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.

Recognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.

Ms. Michaux's work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.