Clinical Regulatory Affairs
Our regulatory team stays abreast of ever changing regulations in the North American market. Our clients have diverse portfolios often crossing different regulatory categories. We take the stress out trying to understand the differences in regulations, classification and requirements between Canada and the United States. Understanding current regulatory requirements and thinking increases chances for approval and ensures a smooth submission process to minimize development process interruptions.
Understanding the differences in how the intent of a clinical trial drives the need or not for an IND in the U.S. versus classification based on ingredient and safety profiles in Canada, Nutrasource is uniquely positioned to provide guidance to our clients on risks and benefits of study design, country(ies) selected to conduct your clinical trial in and requirements for submission dossiers in either Canada or the U.S.
View our blog post, How to Overcome Common R&D Challenges in the Health Product Industry.
Our team comprises regulatory personnel experienced in foods, dietary supplements and drugs, all dietary supplement ingredient categories and Canadian and U.S. regulations pertaining to clinical research as well as market access. Our philosophy is that regulatory activities are a team effort and assign the appropriate team for your specific programs and collaborate with you to ensure, accurate, truthful and complete dossiers are compiled.
Nutrasource’s expertise across all regulatory categories from dietary supplements and foods to drugs in both Canada and the United States provides you with confidence when interacting on behalf of our Sponsors with the regulatory authorities. Our team ensures complete and appropriate positioning of your regulatory dossier, timely submissions, submission management, and expedited adverse reaction reporting. We view the regulators as a partner and collaborator and work with them to help commercialize your innovations.
Our track record
- Our staff have filed more than 75 Clinical Trial Applications with Health Canada
- >80% of clinical trial applications in Canada receive approval from Health Canada within 60 calendar days and >90% of single dose studies receiving approval in 30 calendar days.
- 50% of our regulatory professionals hold advanced degrees, and each have between 5 and 20 years of experience.
Looking for more information on regulatory affairs? Contact a member of our team today or email us directly at email@example.com. You may also request a customized quote and we will contact you with details within two business days.