Natural Health Products (NHPs)

Natural Health Products include a wide variety of healthcare products based on natural ingredients. They include topical and ingestible products, and some may seem like foods, drugs, or even cosmetics. We have been involved with this category since its inception in January 2004, and can assist in understanding and responding to both current and emerging regulatory issues.

Here are some ways we can help:

Regulatory Affairs

Correctly classify a product – NHP, Drug, Cosmetic, or Food
Prepare applications to Health Canada for product approval (Natural Product Number – NPN)
Assist with product importation to Canada
Manage post-approval NPN changes such as product reformulation or new labeling
Prepare applications for the approval of manufacturing, packaging and warehousing facilities (Site License Approval)

Labeling and Marketing Compliance

Review product labels, inserts, print, and broadcast advertising

Environmental Compliance

Review ingredients for compliance with the Canadian Environmental Protection Act (CEPA)
Complete submissions to Environment Canada
Evaluate organic and environmental claims

Quality Assurance

Conduct Drug GMP audits and host inspections from Health Canada
Prepare and review Standard Operating Practices (SOPs)
Manage consumer complaints and Adverse Drug Reactions (ADRs)
Act as Canadian QA to release product for shipment into Canada

Scientific Affairs

Design and commission stability studies
Prepare finished product specifications
Provide assistance with analytical test methods
Evaluate product/package compatibility
Design and commission clinical trials

Due Diligence

Analyze all technical and scientific aspects of products

Consumer Research

design and conduct concept and product acceptance tests
Interpret existing research data
Conduct focus groups

Claim Substantiation

Design and commission studies pertaining to product performance
Review existing clinical or scientific data in support of packaging or advertising claims