Clinical Testing in Canada & the U.S.: Roadmap, Costs, and Overcoming Challenges for Startups
Overview
Clinical testing is one of the most significant hurdles for biotech and medtech startups, including navigating regulatory approval, costs, timelines, and execution. This webinar provides a practical roadmap tailored for startups actively preparing for clinical trials in Canada and the U.S. Attendees will gain clarity on the stages of the clinical testing process, the real-world costs and timelines involved, and common hurdles startups face along the way and how to overcome them.
👥Who Should Attend
This session is designed for:
Biotech and medtech startups actively preparing for clinical trials
Founders and teams navigating regulatory pathways in Canada and the U.S.
Companies transitioning from prototype or preclinical stage to clinical testing
🎯Learning Outcomes
You’ll walk away with an understanding of:
Product classification under the Food and Drugs Act (Health Canada) and FDA regulations
The roadmap from preclinical stage to commercial launch, with a focus on timelines and costs
Key differences and trade-offs between conducting trials in Canada vs. the U.S.
Common hurdles in regulatory approval, trial execution, and compliance, and strategies to overcome them
What support and resources are available to startups moving through the clinical trial pathway
🧑🔬Speaker Bios
Dr. Nazish Ahmed, Ph.D.
Founder and CEO of Biomanufacturing Solutions, Dr. Ahmed has over a decade of experience in pharmaceutical engineering, regenerative medicine, and cGMP compliance. She has successfully led lab build-outs, process improvements, and regulatory initiatives across biotech and healthcare. With 15 peer-reviewed publications and deep expertise in commercialization, Dr. Ahmed advises startups on navigating the complexities of clinical testing and launch.
Prerna Mistry, M.Sc., CQA (ASQ)
Prerna is a regulatory compliance specialist with extensive experience across pharma, biotech, medical devices, and reproductive tissue. At Biomanufacturing Solutions, she ensures compliance with Health Canada, FDA, and international standards, with a focus on risk management and audit readiness. As a Certified Quality Auditor, she helps startups streamline submissions, overcome regulatory hurdles, and move efficiently through the clinical trial pathway.
Details
📅 Date: October 20, 2025
⏰ Time: 2:00 – 3:30 PM ET
💻 Location: Virtual (link provided upon registration)
👉 RSVP today to save your spot!