Our network of Early Stage companies has grown to become a leader in clinical research and bioanalytical mass spectrometry. With approximately 1000 trained professionals and more than a decade of experience, we are uniquely positioned to support drug discovery and development by innovator companies.

 

Canadian regulatory environment

Canada benefits from a competitive Clinical Trial Application (CTA) process. All applications are subject to a maximum default review period of 30 days.

 

As a PharmaNet Development Group company, Anapharm submits approximately 200 clinical trial applications each year and has built a strong relationship with the agency.

 

	CTAs for straight forward studies involving healthy volunteers should ideally be submitted around 3 to 4 weeks prior to dosing. Health Canada usually reviews these type of CTAs within 7 days.
	CTAs for studies with new chemical entities (such as "first-in-man studies) should be submitted about 5 to 6 weeks prior to initial dosing. For these CTAs, Health Canada’s review period will vary according to the complexity of the drug, but is usually between 15 to 30 days.

 

Anapharm’s professionals will be pleased to assist you in preparing CTA documents and establishing realistic timelines for your study.

 

With a complete range of early clinical and bioanalytical services, strong customer focus, and total commitment to quality, responsiveness, flexibility, and timeliness, we can meet your innovator outsourcing needs.