Sponsors must file a Clinical Trial Application (CTA) to conduct clinical trials in Canada for Phases I through III of drug development and comparative bioavailability trials. This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the authorized Notice of Compliance (NOC) or Drug Identification Number (DIN) application (e.g. using a marketed product for a 'new' indication or using an unauthorized dose etc).
With our many years of experience with Clinical Trial Applications, our staff has assisted many small to medium sized biotechnology and pharmaceutical firms with successful submission filings for a large variety of products and therapeutic areas. We have the experience to assist our clients with their Clinical Trial Applications and strategic consulting needs.
Therapeutic Products Inc., can move your product forward and help you navigate your way through Regulatory Affairs.