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James Gallagher

Senior Associate


James is a Regulatory Senior Associate who advises clients in the healthcare, medical device, digital health, pharmaceutical, cosmetic, software and general consumer product sectors on various regulatory compliance matters. He works with clients on the application of domestic and EU regulatory regimes throughout the life cycles of their products and regularly advises on matters such as the applicability of regulatory frameworks, approval and authorisation, labelling, packaging, traceability, recalls, safety and liability. James also represents clients in contentious product liability matters, advises on regulatory investigations by enforcement authorities and represents clients in enforcement actions, including the defence of criminal prosecutions for breaches of consumer protection legislation.

James holds an MSc in Food Regulatory Affairs and also advises food and beverage clients on a range of domestic and EU regulatory matters specific to the food sector.

Specialties

  • Life Sciences Regulatory: Pharmaceutical, Medical Devices & Cosmetics
  • Digital Health/AI
  • Product Regulatory, Safety and Recall
  • Product Liability
  • Food Regulatory Law

Representative Matters

  • Advising various clients in the medical device and digital health sectors, including software medical devices and apps, on various regulatory compliance matters relating to the transition from the Medical Device Directive to the Medical Device Regulation
  • Professional regulatory and product liability advice in relation to a pilot scheme for the rollout of an IT platform developed by a medical device manufacturer in partnership with a software company, to be used by healthcare professionals
  • Advising a multinational spirits company in relation to labelling and marketing of products as well as compliance with geographical indication verification regimes
  • LinkedIn

Areas of Expertise

Life Sciences Product Regulation & Consumer Law Food, Agriculture & Beverage

Professional Memberships

Law Society of Ireland

TOPRA

British Institute of International and Comparative Law (BIICL)

Education

Trinity College Dublin, BA(Mod) – Business and Politics

University College Dublin, MSc – Food Regulatory Affairs

Honorable Society of King’s Inns, BL