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Clinical Trial Applications
In Canada, a pharmaceutical, a biologic or a radiopharmaceutical drug, must prepare and submit a Clinical Trial Application (CTA) to Health Canada, which includes the required paperwork for review by Health Canada for the purpose of obtaining authorization to proceed with your clinical trial.
- It will take Health Canada as little as 30 days to review (target review)
- Sponsors have two days to respond to questions from Health Canada. This to secure their efficient 30-day review target; exceptions may apply.
Clinical Trial Application Track Record
NUMBER OF SUBMISSIONS
Over 1500 submissions in the past 10 years
SUBMISSION SUCCESS RATE
Near 99% submission success rate
GLOBAL CLIENT LOCATIONS
SPharm has delivered regulatory services to clients in 15 different countries
The global development process can be both lengthy and complex because it involves in-depth research and key document preparation such as the Protocol, Investigator Brochure (IB), and Informed Consent Form (ICF), as well as some related summaries. It also requires rigorous regulatory submission preparation and submission to the regulatory authorities.
Our Clients' Success...Is Our Success
“SPharm truly are Canada’s Drug Regulatory Experts! An exceptional team, lean and efficient with 100% understanding of Health Canada. They are the perfect partner in their field, seamless, proactive, prompt! We’ve worked with them for over 20 years and when I meet with sponsors, I openly recommend SPharm for any regulatory needs in Canada.”
Julie Martin
CEO and Co-owner, Scimega
“The opportunity to work with Susanne and SPharm for over 20 years testifies to the quality of work and the relationship one experiences with the SPharm team. They became an extension of our own, our success enriching our relationship over the course of business in parallel with a great friendship.”
Jean De Serres, MD, M.Sc, MBA, I.As,
VP Scientific Affairs and Operations, Paladin Labs
“We have had the pleasure of working with SPharm since the inception of our company, and since then SPharm has consistently exceeded our expectations in terms of service, timeliness, and deliverables. They have been a key factor in the success of our pharmaceutical company.”
Robert Vinson, Ph.D.
Chief Innovation Officer, Searchlight Pharma Inc.
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