Successfully executing a clinical trial requires knowledge of the current regulatory requirements and an understanding of how changes will impact your project. A deep understanding of regulatory body thinking, and longstanding experience liaising with regulators, increases your chances of approval and ensures a smooth submission process to minimize development process interruptions.
At Nutrasource, we have unmatched expertise working with clients across all regulatory categories, from dietary supplements and foods to drugs in both Canada and the U.S. We view the regulators as partners and collaborators, working with them to help commercialize your innovations.
Our regulatory team stays abreast of the ever-changing regulations to take the stress out of understanding the differences between Canada and the U.S. Our philosophy is that clinical regulatory activities are a team effort. At Nutrasource, our team has detailed knowledge of foods, dietary supplements/natural health products, and pharmaceuticals at all stages of the R&D process and product life cycle. We assign the appropriate team for your specific project and collaborate with you to compile accurate, truthful, and complete dossiers.
Nutrasource is uniquely positioned to provide guidance on risks and benefits of study design, the country or region to conduct your clinical trial in, and the requirements for submission dossiers.
Our clients benefit from Nutrasource’s strong track record in clinical and regulatory affairs. Our team has:
- Filed more than 75 Clinical Trial Applications (CTAs) and Investigational New Drug (IND) submissions with Health Canada and the U.S. FDA
- Received approval from Health Canada within 60 calendar days for >80% of Clinical Trial Applications
- Received Health Canada approval within 30 calendar days for >90% of single-dose studies
Learn how we can help you assess the strategic regulatory considerations for your clinical trial.
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