Winston Kirton advises both domestic and international companies that are facing regulatory challenges involving products and services regulated by the FDA, including biopharmaceutical, medical device, food and dietary supplements, in connection with corporate transactions, research and development, manufacturing and supply chain, and commercial regulatory and compliance matters. He also advises clients regarding legal disputes related to third-party contract manufacturing relationships, third-party supplier relationships and alliance-partner relationships.
Due to his significant experience with the complex FDA requirements, Winston is able to guide clients and their most significant deals through all aspects of FDA regulatory due diligence. He provides comprehensive advice to clients facing legal and regulatory challenges with products and services regulated by the FDA, including on how to address the FDA regulatory process.
Winston accumulated in-depth international legal and business life sciences experience through a variety of in-house positions at several large multinational biopharmaceutical companies, particularly in the areas of quality and compliance, regulatory affairs, compliance and ethics and legal affairs. This allows him to provide clients with a holistic view of their regulatory matters when combined with his knowledge of the regulatory process for pharmaceuticals, medical devices, foods and dietary supplements.
Winston previously served as the head of compliance and ethics, while based in London, for a multinational U.S. pharmaceutical company, and was responsible for business units comprised of Latin America, Central and Eastern Europe, Middle East-Asia-India, China and the Pacific Rim regions.