The natural health products and dietary supplement business is currently estimated to exceed $400 billion in worth. Dietary supplements account for nearly $40 billion in sales, and in Canada, sales from natural health products exceed $5 billion. 

The industry is very strictly regulated, but the markets make the navigation of regulatory minefields worth it. Prophema provides all the support necessary to gain a strong place in the market while adhering to regulatory strictures. 

Natural Health Product (NHP) Services for Canada:

• NHP Product Licensing
• Substantiating Health Claims 
• Assistance with product development
• Site licensing for NHP development
• GMP Compliance
• Supplier Qualification
• NHP importation and border control issues resolution
• NHP clinical trials
• Pre-submission meetings with Health Canada’s Natural and Non-prescription Products Directorate
• International Trade Certificates (ITC) & certificates of GMP Compliance

Dietary Supplement Services for the United States:

• FDA product compliance
• Health claim substantiation and product development
• FDA cGMP Compliance
• FDA supplier qualification
• Dietary supplement clinical trials
• New Dietary Ingredient (NDI) Assessment and Notification Filing
• Adverse event reporting
• Dietary supplement label review
• Import & border control issue resolution
• Amazon dietary supplement requirements