Toothpaste sounds simple. It sits on store shelves next to shampoo and soap, and most consumers never think twice about it. However, for anyone managing
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The question of whole ingredient vs extract GRAS requirements comes up constantly when companies formulate with botanicals, functional ingredients, or novel actives. Many regulatory teams
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When you submit a product licence application for a natural health product in Canada, your submission does not enter a single universal queue. Health Canada
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Getting an FDA 510(k) submission right the first time is one of the most consequential steps in your medical device’s path to market. The 510(k) premarket notification process
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If your company holds or is applying for an NHP site licence, the way you send submissions to Health Canada has changed. As of March 30,
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Weight loss supplements are one of the most commercially attractive categories in the dietary supplement industry, and one of the most closely scrutinised. For companies bringing
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You have a protein product ready to bring to market in Canada, and classifying it correctly is holding up your launch. The distinction between protein
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If you are bringing medical devices to the Canadian market, one of the first compliance questions to resolve is whether you need a medical device
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As of January 2026, Health Canada’s Regulatory Enrolment Process (REP) is mandatory for all Class II, III, and IV medical device licence (MDL) applications. This change, signalled since
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Health Canada issued updated versions of both its Primary Sunscreen Monograph and Secondary Sunscreen Monograph on December 19, 2025, replacing the versions that had been in place
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Cannabis edibles are one of the most tightly regulated product categories in Canada — and one of the most commercially attractive. The requirements cover everything
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When Health Canada amended the Cosmetic Regulations to introduce fragrance allergen disclosure requirements, the industry pushed back fast. The fragrance allergen concentration requirements, specifically the
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