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Marie Doyle-Rossi

Associate
Marie Doyle-Rossi

Marie Doyle-Rossi is an Irish and UK qualified lawyer with a Ph.D. in biology. Her practice focuses on life sciences regulatory, commercial and administrative law matters. She has specialized experience in GxP matters and navigating the regulation of complex technologies, including advanced therapeutics, biologics, combination products, digital health and personalized medicine.

Dr. Doyle-Rossi provides strategic, policy and regulatory advice on biologics, orphans, human tissue and cells, market and data exclusivity, clinical trials, pricing and reimbursement, product life-cycle management, data privacy and compliance issues.

Non-contentious

  • Assisting clients with applications for the centralized approval of medicinal products and for orphan drug designation, and with regulatory issues in the national approval process for medicines, including the decentralized and mutual recognition procedures.
  • Strategic and regulatory advice to clients developing products to address COVID-19, and counselling pharmaceutical and medical device companies otherwise impacted by the public health emergency.
  • Regulatory advice on product classification issues, including the borderlines between medicines, medical devices, humans tissue and cells, cosmetics and combination products.
  • Counseling clients on “Brexit” related issues, including implications for supply chains and the Northern Ireland Protocol.
  • Compliance advice to pharmaceutical and medical device companies on applicable marketing laws and codes of practice.
  • Advising clients on GxP matters, including good manufacturing practices (GMP), good clinical practices (GCP) and good pharmacovigilance practices (GVP).
  • Advice on controlled substances, including the legal landscape surrounding the development and marketing of CBD products.
  • Participation in compliance-related investigations and initiatives in respect of alleged breaches of medicines advertising, anti-bribery, clinical trials, and pharmacovigilance rules.
  • Coordinating international projects on clinical research, advertising/promotion, and the regulatory classification of borderline products.
  • Regulatory and commercial due diligence for pharmaceutical, medical device and food companies.

Contentious

  • Representation of pharmaceutical clients in proceedings before the European General Court relating to the transparency of clinical trial data.
  • Representation of a multinational pharmaceutical company in pharmacovigilance enforcement proceedings before the European Medicines Agency.
  • Representation of global pharmaceutical clients in judicial review proceedings in the UK courts, including challenging the use of an unlicensed medicine.
  • Advice and representation of clients before the National Institute for Health and Care Excellence (NICE) on pricing and reimbursement matters.
  • Successfully represented clients in relation to advertising disputes before the Prescription Medicines Code of Practice Authority (PMCPA).
  • Representation of a large U.S. pharmaceutical company in a product liability class action relating to blood products.

Pro Bono

  • Successful representation of the charity, Solving Kids Cancer, in NICE appeal proceedings.
  • Representation of a couple in UK judicial review proceedings in challenging a decision of a UK health authority to refuse medical treatment.
  • Advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives.
  • Counselling the Sabin Vaccine Institute and Sabin Foundation Europe on commercial matters.

Previous Experience

  • Seconded to the international office of a U.S. biotechnology company, as the interim Legal Director for the UK, Ireland, Nordics and Australia.
  • Seconded to the in-house legal department of an international pharmaceutical company, based in Zurich.
  • School of Pharmacy, University College London, Wellcome Trust Research Fellow (2006-2008)
    • Development of novel antibacterial agents in collaboration with a spin-out biotechnology company.