Elisabethann Wright

Elisabethann Wright specializes in EU law and regulation of pharmaceuticals, medical devices and digital health, food and cosmetic products. Her advice is regularly sought due to her extensive knowledge and experience of EU legislation, technical competence and commercial acumen. She has been practicing in the life sciences sector for almost 40 years in private practice and international institutions. Elisabethann supports clients through the procedures and regulations necessary to place and keep their products on the European Union market through strategic advice, advocacy before institutions and agencies and litigation before EU and EFTA courts. Her experience covers the full regulatory life cycle of products: classification of their products, establishment of a pathway to authorization, or CE marking and promotion and marketing of their products in the EU, including related regulatory obligations, pharmacovigilance obligations, conformity assessment of medical devices, promotion and marketing of products including assistance in development of compliance policies and participation in MRCs and PRCs, development of quality, supply, sales, and services agreements, clinical trial agreements, adverse event reporting, product withdrawals, and conduct of compliance and anti-bribery investigations.