How a product is classified can affect its entire life cycle, from early development to clinical research strategy, health claims substantiation, and positioning. The product type and its ingredients may span multiple regulatory categories, presenting different options for categorization and market entry. Ultimately, the label claims and safety profile dictate the appropriate classification.
Understanding the nuanced requirements of different categories can present new opportunities for market access. Our regulatory team will work with you to weigh the risks and benefits of different classification options and determine the optimal pathway depending on your objectives.
Learn how we can help you classify your product based on your needs and objectives.
Case Study: Complex Multi-Ingredient Products Can Be Effectively Studied to Ensure Optimal Dosing for Future Studies
Learn how Nutrasource assisted a Sponsor in determining optimal dosing.