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Health Canada’s Therapeutic Products Directive (TPD) is the federal authority that regulates pharmaceutical drugs and medical devices for human use.  A Clinical Trial Application (CTA) must be filed before the initiation of a clinical trial in Canada.  Sponsors must file applications to conduct clinical trial in Phases I through III of drug development and comparative BA/BE trials. This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) of Drug Identification Number (DIN) application:


  • For BA or BE studies, CTA is filed with Health Canada 2-3 weeks before dosing.  Health Canada has aggressively maintained the 7-day administrative review target
  • For Phase I-III studies, a CTA is filed with Health Canada 4-6 weeks before dosing.  The review typically takes 10-15 calendar days although the default review period is 30 days
  • More than 95% of our clients worldwide take advantage of our in-house regulatory service, which ensures seamless submissions of CTAs relative to IRB submissions

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