Life Sciences Regulatory Expertise

Our specialist life sciences regulatory lawyers offer clear and practical legal advice to a variety of clients across the life sciences industry including global pharmaceutical, medical device, cosmetic and technology companies.

As the only specialist standalone life sciences regulatory team in Ireland, we have significant experience acting as EU regulatory counsel to many global and Fortune 500 life sciences and technology companies.

Our team has extensive experience advising companies on all areas of regulatory compliance through the life cycle of a product This includes advising clients on all issues they encounter on the EU market from R&D, marketing authorisations & CE marking, packaging, market access, product launch and marketing, reimbursement, through to safety issues, product recall and defending product liability claims. The team is internationally recognised in particular for its specialist expertise in digital health, wearables and software medical devices.

The team also advises clients on regulatory investigations by enforcement authorities, including the Health Products Regulatory Authority and The Competition and Consumer Protection Commission and the Advertising Standards Authority for Ireland.

We have also overseen the implementation and coordination of high volume product withdrawals and product recalls, including rectification strategies, in multiple jurisdictions.

The team also has extensive experience in defending product liability claims on behalf of life sciences companies, further details of which can be found here.