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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, the former Soviet Union, Africa, the Near 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 recognised by Chambers UK, Life Sciences as "a knowledgeable lawyer with a strong presence in the industry," whilst Chambers Global sources report that "he worked in the sector for many years, and has a thorough understanding of how the industry ticks."
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.
Previous Experience
- Glaxo Group Research, Medicinal Chemist (1991)
Honors and Rankings
- Super Lawyers - London, Administrative and Public Law (2013)
- Chambers UK, Life Sciences: Regulatory (2009-2013)
- Chambers UK, Product Liability - Food (2013)
- Chambers Global, Life Sciences - Regulatory/Compliance (Global-wide) (2011-2013)
- The International Who's Who of Life Sciences Lawyers (2011-2012)
- PLC Which Lawyer?, Life Sciences, Regulatory (2008-2012)
- Legal 500 UK, Pharmaceuticals and Biotechnology (2008-2012)
- Legal 500 UK, Product Liability, Defendant (2011)
- Legal Experts UK (2010)
Publications and Speeches
- Numerous publications in the legal and regulatory literature and several contributions to the technical literature in chemistry.
- Frequent lectures on pharmaceutical, medical device, data privacy, and borderline products regulatory issues.
- "Practical Experience of the New Pharmacovigilance Legislation" and "In-house Counsel and Private Practice Panel Discussion: Regulatory Frameworks," Informa Life Sciences’ 22nd Annual EU Pharmaceutical Law Forum (5/14/2013)
- "European Union," The Life Sciences Law Review (April 2013), Co-Author
- "United States," The Life Sciences Law Review (April 2013), Co-Author
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