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Regulatory Agencies Health Canada

Husch Blackwell LLP

Clinical Trial Audit Readiness: A Step-by-Step Guide for Research Sites

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Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more

Goodwin

Guidance on Biosimilar Submission Requirements in Canada

Goodwin on

Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for...more

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