Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.
His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products.
He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, Russia, Africa, the Middle East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.
Mr. Castle is a visiting lecturer at the University of Surrey, on a course leading to a Master of Science in Pharmaceutical Medicine/Clinical Pharmacology; Cardiff University, on a course leading to a Master of Science/Diploma in Clinical Research and on the Postgraduate Course in Pharmaceutical Medicine; and, Cranfield University, on a course leading to Master of Science, Postgraduate Diploma, and Postgraduate Certificate in Medical Technology Regulatory Affairs. Mr. Castle is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players” in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “‘highly competent in understanding legal and technical biological issues.”
Representative Matters
– Regulatory advice to many of the major national and multinational pharmaceutical companies and a wide array of biotechnology, diagnostic, medical device, and consumer product manufacturers in the United States, United Kingdom, mainland Europe, and elsewhere.
– Assistance to clients with applications for the centralized approval of medicinal products and for EC orphan drug designation, and with regulatory issues in the national approval process for medicines, including the EC decentralized and mutual recognition procedures.
– Regulatory advice to the Pharmaceutical Research and Manufacturers of America (PhRMA), the primary US industry trade association, and participation in PhRMA European Regulatory Team and the PhRMA Pharmacovigilance Working Group.
– Participation in formal and informal good manufacturing practices (GMP), good clinical practices (GCP), clinical trials, advertising, borderline, drug safety, and pharmacovigilance regulatory and enforcement proceedings before the European Medicines Agency (EMEA), national authorities, courts, and self-regulatory bodies.
– Participation in pharmaceutical and medical device reimbursement proceedings before the UK’s National Institute
– Judicial review proceedings in the UK and EC courts, including the first challenge to a Community marketing authorization for a medicinal product in the European Court of First Instance.
– Participation in compliance-related investigations and initiatives in respect of alleged breaches of medicines advertising, anti-bribery, clinical trials, and pharmacovigilance rules.
– Product defense resulting from regulatory challenges to product claims and borderline product classifications.
Previous Experience
– Glaxo Group Research, Medicinal Chemist (1991)
Accolades
– LMG Life Sciences Europe, Life Sciences Star – Regulatory (United Kingdom) (2014-2015)
– Chambers UK, Life Sciences: Regulatory (2009-2019)
– Chambers UK, Life Sciences (2014-2018)
– Chambers UK, Product Liability – Food (2013-2014)
– Chambers Europe, Life Sciences (2015, 2017-2019)
– Chambers Global, Life Sciences (2011-2018)
– Super Lawyers – London, Administrative and Public Law (2013)
– Who’s Who Legal, Life Sciences (2011-2017)
– Legal 500 UK, Pharmaceuticals and Biotechnology (2008-2016)
– Legal 500 UK, Product Liability, Defendant (2013-2016)
– PLC Which Lawyer?, Life Sciences, Regulatory (2008-2012)
– Legal Experts UK (2010)
