Timothy Squire's practice is devoted to the regulation and commercialization of drug products, medical devices, food, natural health products and other types of life science innovation.
Tim brings a unique perspective to the firm's Life Sciences Group given his considerable knowledge and experience across the entire health product lifecycle. Tim has become a trusted advisor to many large and small drug, device and food manufacturers with operations in Canada. He also performs in-house legal functions for several U.S. and international clients without Canadian in-house legal or regulatory capabilities, and in this capacity has developed a comprehensive understanding of the business issues and pressures facing companies in the life sciences industry.
Tim's regulatory practice covers all aspects of health product regulation, including clinical trials and good clinical practices, market authorization, special access programs, the operation and application of the Patented Medicine (Notice of Compliance) Regulations, data protection under the Food and Drug Regulations, quality management, site and establishment licensing, packaging and labeling, food claims and GMP, promotion and advertising, product recalls and adverse event reporting, pricing and mandatory price reporting, provincial drug benefit plans including formulary eligibility and listing, and interaction with regulators throughout the product lifecycle including responses to government audits and enforcement actions. Tim also crafts corporate policies which implement a wide range of regulatory requirements, as well as corporate ethics and anti-corruption policies.
In addition to his regulatory expertise, Tim's practice also involves the commercialization of health product innovation. Tim negotiates and drafts sophisticated intellectual property agreements (including licenses, technology and material transfer agreements, joint R&D agreements, funding agreements, and employee, consultant and content specific confidentiality agreements), distribution and service agreements, and manufacturing and associated quality agreements. Tim is also called upon to quarterback intellectual property and regulatory due diligence in complex domestic and cross-border transactions involving drug, device and food companies and product lines, and to manage the transition of market authorizations, intellectual property assets and other regulatory matters post acquisition.
Tim works closely with other specialists at Fasken including corporate, tax, intellectual property, government relations, litigation and employment lawyers to provide clients in the life sciences industry with a complete range of integrated legal services.
Tim appeared on the cover of the May 2016 edition of Lexpert Magazine and was quoted in the Life Sciences Feature Article.