Clinical Regulatory Affairs
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.