Torys' practitioners are deeply experienced in the relevant regulatory laws, guidelines and policies – both federal and provincial – and regularly advise on all of the regulatory issues affecting the research, testing, approval, post-approval compliance, pricing, advertising and correction/withdrawal/recall of drugs, food and beverage products, cosmetics, consumer products, nutritional products, and medical devices/diagnostics products in Canada.
Our expertise includes the following:
- classification of products
- product monographs, packaging, labelling,
education and advertising
- corporate compliance codes, and product
and company websites
- obtaining regulatory approvals, including
pre-submission meetings with regulatory
authorities (NDS, SNDS, IND, DIN and
other license submissions)
- pricing and market access of products,
including medicines, medical devices/diagnostics, including PMPRB
- public and private formularies and
agreements with such formularies
- formulary listing strategy
- patient and physician support websites
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- research and clinical trials, and consents and privacy issues related to the use of data or biological materials
- protection of and access to data
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interfaces between regulatory submissions, patent listings and data protection
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follow-on biologics
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advertising complaints and disputes before PAAB, ASC and other organizations (brought by or against competitors)
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compliance and cross-border issues in corrective actions, recalls and withdrawals
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research, grant, clinical, funding, confidentiality, consulting, packaging, marketing, supply, promotion, advertising, distribution and other agreements |