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Home » Regulatory Regulatory



We understand the complete Canadian Product Registration process

Our affiliated regulatory division has been in private practice for 25 years and possesses unique skills to help our clients navigate through the regulatory channels of the Canadian Food and Drugs Act.

It is uncommon to find a contract manufacturer with such depth of knowledge available in house and available as a valued-added service.

Our unique skill is to understand the complete product registration process and to communicate potential cost consequences to product marketers before rather than after.

In Canada, a natural health product must be licensed with a natural health product number (NPN) prior to sale.

Due to administrative challenges the Natural Health Product’s Directorate permits markets of natural health products to sell products with submission numbers. The approval process is a long journey but requires important information that is intimately ties to the manufacturing process such as Finished Product Specifications.

Finished Product Specifications are the tolerance limits that you assign to the individual product and has four (4) different levels of information:

1. Physical characteristics (colour, odour, appearance);
2. Active ingredient potency (is it in the product and at what level?);
3. Microbial purity (is the product free from any bacterial contamination?)
4. Chemical purity (are there any chemical contaminants such as arsenic, lead, mercury
or cadmium; are there any manufacturing solvent residues and of course are there any
pesticides?)

Our regulatory department is well equipped to handle all of these questions and more as you navigate the NHP product license landscape.

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