Depending on your product goals and markets of interest, your company may require a Drug Establishment Licence. Applicable in Canada, a Drug Establishment Licence is required for any company that fabricates, packages, labels, distributes, imports, wholesales, and/or tests drugs.

A Drug Establishment Licence allows the licensee to legally engage in any authorized activities and signifies Good Manufacturing Practice (GMP) compliance. The goal is to verify that the Canadian pharmaceutical market consists of safe, high-quality drugs.

Our regulatory management team will gather and assess your facility’s SOPs and associated documentation and assess the facility against the drug’s GMPs as part of the inspection and licensing review. We will work collaboratively with your team to identify any quality-related gaps so you can gain market access quickly and with regulatory confidence. Explore our additional services for pharmaceuticals.

Learn how we can help you obtain a Drug Establishment Licence for the Canadian market.


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