Combining legal skill with solid industry knowledge, we represent many of Ireland and the world’s major pharmaceutical, medical devices and agri-business companies, ranging from start-ups and university spin-outs to large multinationals and industry leaders.

Our Life Sciences Group advises on all aspects and stages of the life cycle of a product, from research and development through to manufacturing and marketing of finished products. Our extensive experience in this sector, allied with strong links with local and EU trade and regulatory associations, enables us to anticipate and identify potential issues in advance, thereby ensuring the smooth operation of our clients’ businesses. It is for this reason that we count many of the world’s leading pharmaceutical, medical device and biotech companies amongst our clients.

We advise our life science clients in the following areas:

Regulatory and Compliance

We offer experienced legal, regulatory and strategic advice in an evolving EU and Irish pharmaceutical, biotech, medtech, digital health, food and cosmetics market. The team advises on clinical trials, product classification, CE marking, promotional activity, export control, Competent Authority inspections, market access, pricing and reimbursement. For more, click here.

Infrastructure and Manufacturing

We have market leading experts in the development of life sciences manufacturing projects across all relevant legal sectors including real estate, environment and planning, grant aid, construction, capital equipment, services, regulation and utilities. We provide solution focused advice across the lifecycle of acquisition, development, upgrade, expansion and, in some cases, sale and leasing of manufacturing facilities. For more, click here.

Transactional

We advise on the negotiation and structuring of a variety of transactions including mergers, acquisitions, migrations, inversions, pre-sale spinouts or hive downs, business and product acquisitions and disposals, restructurings, reorganisations, cross-border mergers, distributions, joint ventures, corporate structures and related structural issues. For more, click here.

Product Liability

We advise our clients on product liability claims, product recall, crisis management strategies, risk assessments, labelling and packaging issues, investigations by regulatory authorities and specialist insurance advice. We act regularly as national counsel in multiparty and cross-jurisdictional litigation. We have an outstanding track record in advising clients on disputes arising from all stages of the product life cycle, including development, production, packaging, importation, distribution and marketing. For more, click here.

Digital Health

We combine subject-matter experience, in-depth industry knowledge and strategic problem-solving to advise our clients in relation to novel legal and regulatory issues in this rapidly evolving sector. Our clients include multinational and start-up pharmaceutical companies, medtech and biotech manufacturers, healthcare organisations, research institutions and telemedicine providers. For more, click here.

Relevant Experience

• Advising on restructuring and regulatory aspects of the Endo Pharmaceuticals Chapter II
• Advising on the Amgen/Horizon acquisition and integration
• Advising Takeda on the acquisition by MSD of its Dunboyne manufacturing facility
• Advising Emergent BioSolutions on its $635 million acquisition of Adapt Pharma
• Advising on a pharmaceutical business on addressing issues arising from a competition authority audit
• Advising numerous pharmaceutical companies on pricing, reimbursement and access to medicines in Ireland
• Advising a multinational pharmaceutical company on the regulatory aspects of the restructuring of its Irish subsidiaries and related marketing and manufacturing authorisations
• 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 national screening service on the drafting and negotiation of a major contract in relation to testing services and a national screening programme