Access to Canadian and U.S. Markets

To sell a natural health product (NHP) in Canada, it requires a Natural Product Number (NPN), a product licence issued by the Health Canada Natural and Non-prescription Health Product Directorate (NNHPD) to ensure safety, quality and efficacy of the products sold in the market.

We accompany you throughout the process:

• Product evaluation
• Discussion to establish the best regulatory strategy for this product
• Creation of supportive documents needed for the product application 
• Label revision (French and English)
• Preparation and submission of Product Licence Application (PLA)

A Product Master File is an interesting alternative in the event you prefer keeping confidential certain manufacturing/processing steps of the medicinal ingredients/raw materials. 

Please contact us for more information

The US FDA defines Generally Recognized as Safe (GRAS) as any substance intentionally added to food that is considered safe by experts under its intended use. 

A notification must be submitted to the FDA prior putting on the market a dietary supplement containing a new "dietary ingredient",  which is defined as a dietary ingredient that was not marketed in the United States as a dietary supplement prior October 15, 1994.

 Unclear if you shoud take the GRAS application or a New Dietray Ingredient Notification (NDIN) for your product? We are here to guide you on the best route to take for your product. 

We accompany you throughout the process:

• Product evaluation
• Determine if your ingredient falls under GRAS or NDI
• Compiling of the information and detailing any additional data required
• Preparation and filing of the complete dossier
• Addressing any questions from the FDA

We also offer a dietary supplement label review service to ensure :

• Accurate structure/function claim for the product
• Appropriate ingredient listing and ordering
• Accurate Supplement Facts Panel (SFP) information and display

Please contact us for more information