Our Projects

Method validation is an important quality assurance tool used to demonstrate whether an analytical method is fit for its intended purpose. It helps assess the accuracy, precision, sensitivity, range, specificity, limit of detection, limit of quantification, and system suitability.

Method validation is an imperative aspect of our work and a vital step in confirming the integrity of a natural health product. Without an accurate, precise and reproducible method, manufacturers cannot confirm that their products meet their required specification. The Canadian Natural Health Products Directorate GMP Guidance Document states that manufacturers must confirm that their products meet required specifications.

For example the AOAC ™ has officially approved the method of analysis for cannabis published by Dr. Paula Brown, BCIT Canada Research Chair in Phytoanalytics and Director of Natural Health and Food Products Research Group (NRG).

Laboratory proficiency

The NHP Analytical Laboratory Proficiency Program was designed to increase the reliability and credibility of BC natural health products through robust assessments of analytical laboratory proficiency. Using certified reference material and validated methodology, this program certifies analytical laboratories based on the outcome of proficiency exercises and inter-laboratory comparisons. Participating labs are required to demonstrate their ability to produce consistently accurate results.

Collaborative studies

As the reference laboratory for collaborative studies, we recruit analytical laboratories that offer natural product testing using the specified equipment and instrument capabilities. We provide participating laboratories with certified reference standards, blind samples (i.e. raw material and formulations) and an analytical method that has been validated according to AOAC International guidelines. Results from participating laboratories are evaluated and compiled into a final report which is approved by an Expert Advisory Committee (EAC) of government members and industry stakeholders. When successful, the methods used in collaborative studies may qualify as Official Methods of Analysis (OMA). OMAs are the official, legal methods in the US and are recognized internationally.

Natural Health Products require a site license and a product license to be marketed in Canada. License applications are submitted for review through Health Canada’s Natural Health Product Directorate (NHPD). Once a product is found to be in compliance with the requirements of the Natural Health Product Regulations and is approved for safety and efficacy, its label will bear a natural product number (NPN) or a homeopathic identification number (DIN-HM).

Product license

We assist clients in evaluating the efficacy, safety and quality information of their products with the goal of making them eligible for licensing. The first step in this process is a preliminary product review and recommendations. We identify critical gaps in the standards of evidence for the efficacy, safety and quality of the product within the framework of Canada’s Natural Health Product Regulations. We provide recommendations on how to proceed with the NHP license application process and whether changes must be carried out in order to make an appropriate health claim for the product.

We upload completed NHP Product License applications and supporting documentation to the E-Submission Builder software. Once in “hcs.” format, the application is submitted securely online to the NHPD via Canada Post ePoste.

Site license

We facilitate the NHP site license application process by providing advice and support. A site license application will require six months of quality assurance records and details concerning a product’s manufacture, packaging, labelling and distribution. In order to be licensed, manufacturers, packagers, labellers and importers must show that they follow good manufacturing practices (GMPs).