When competition is fierce, make clinical research and strong claims your competitive advantage.
With new products being developed every day, standing out is becoming more difficult. Regardless of health area or product type, what creates that connection with your customer is the claim on the label.
Strengthen the claims you can make, and get to market faster, with a clinical trial tailored to your unique formulation – and what it can do.
In Canada, natural health products have unique clinical research requirements. Before a phase I, II, or III clinical trial can be carried out on a natural health product, it must be approved by Health Canada. To gain this approval, the sponsor must complete and submit a Clinical Trial Application (CTA) to the NNHPD.
At SNI, we have spent the past 20+ years expediting regulatory approvals to get natural health products on the shelf. As a result, we intimately understand the roadblocks you’re likely to face on the road to commercialization, and how to develop a solution that gives you the best chance at success.
Our clinical research expertise, paired with regulatory affairs, allows our team to create a solution that meets your unique needs.
We can help you:
- Assess market potential for your ingredient or formulation
- Create a compelling, compliant claims validation strategy
- Recommend appropriate health claims prior to regulatory review
- Develop a strong clinical research strategy and execution plan
- Determine study feasibility
- Design a trial that meets your market launch objectives
- Complete and submit your Clinical Trial Application (CTA) to Health Canada, when required
- Conduct and manage your clinical trial, from early stage through phase IV
- Submit and manage amendments and notifications to your CTA, when required
- Recruit study participants at our Winnipeg clinic
- Achieve full regulatory compliance, from the claims you’re making to packaging and labelling