Sara Zborovski practises regulatory, commercial and intellectual property law. She assists companies regulated by Health Canada in obtaining market access and in all areas of compliance. Ms. Zborovski has experience in a wide range of matters involving the innovative pharmaceutical and biotechnology, natural health product, medical device and food and beverage industries.
Ms. Zborovski advises clients on product classification, clinical trials, market authorization and market access strategies, including clinical trial applications and agreements, product licence strategies, market access strategies (including assistance with the Common Drug Review and formulary listings) and establishment licensing and GMP programs. She also assists companies regulated by the Patented Medicine Prices Review Board.
On the compliance side, Ms. Zborovski assists clients in developing SOPs and compliance policies, ensuring compliant packaging and labelling (including label reviews) and provides strategic advice on advertising and marketing programs (including assistance with pre-clearance agencies and representing companies in disputes before the Pharmaceutical Advertising Advisory Board and Advertising Standards Canada). She also advises clients on federal and provincial privacy laws, particularly as these relate to healthcare, and federal and provincial access to information and freedom of information matters.
Ms. Zborovski also works with clients in all industries on matters relating to product safety, including crisis management, advocacy before the inspectorate and product recalls.
Ms. Zborovski has particular experience with Federal Court review of regulatory decisions, lobbying and the Patented Medicines (Notice of Compliance) Regulations. She is an active member of the Canadian IP and advocacy communities, a regular contributor to a number of publications and an active blogger on food safety and other regulatory matters.