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!