Stay compliant with FDA drug establishment and listing renewal requirements before December 31, 2025. Learn key steps and how to file correctly.
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FDA’s FY 2025 OMUFA fees are due June 22 for OTC drug manufacturers and contract facilities. Learn what this means and how to stay compliant.
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Health Canada’s update changes how drug product submissions must be filed. Learn what’s new and how to stay compliant.
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This article breaks down the 3 main pathways for drug submission in Canada: NDS, SNDS & ANDS. Choose the right one for faster market & lower cost.
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Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict
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In the pharmaceutical industry, proper drug submission management is crucial to the success of any drug development process. The submission
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Many drug industries are working in every country. To sell any OTC drug in Canada is not possible without
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Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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Learn how to classify your product as a drug, NHP, or cosmetic in Canada. Understand key decision-making criteria, borderline examples, and what regulatory path you need to follow to stay compliant with Health Canada.
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1. What are over-the-counter drug products (OTC drugs)? Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can
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