The Life Sciences Group at Arthur Cox offers experienced legal, regulatory, and strategic advice in a competitive and evolving EU and Irish pharmaceutical, biotech, medtech, food and cosmetics market. The Group partners with clients through the lifecycle of products from development right through to marketing, providing specific advice on all aspects of regulatory and compliance.

Relevant Experience

• Advising life sciences businesses on export control and sanctions compliance, in particular in relation to the export of goods covered by the dual use regulations and sanctions imposed on third countries.
• Advising a leading Irish healthcare institution on establishing a multi-jurisdiction framework for conducting clinical trials and investigations of medicinal products and medical devices.
• Advising a multinational pharmaceutical company on preparation for Competent Authority inspections.
• Advising manufacturers, brokers and wholesalers of medicinal products on their registration requirements, the Falsified Medicines Directive and their obligations in relation to the licensing, importation and distribution of medicinal products.
• Advising a market-leading medical devices company on the regulation, including the CE marking, of medical devices in Ireland, and on the packaging and labelling requirements.
• Providing advice in relation to disclosure of payments to healthcare professionals and healthcare organisations and other related transparency requirements.
• Advising US pharmaceutical companies on the promotion of prescription medication in Ireland and the EU.
• Advising food supplemental manufacturers on the promotion of food substances in Ireland and the EU.
• Advising a multinational pharmaceutical company on the regulatory aspects of the restructuring of its Irish subsidiaries and related marketing and manufacturing authorisations.