We bring extensive experience and expertise to get your natural health product to market quickly, efficiently and compliantly. Our roots stem from the Natural Health Products industry. Over the years we have developed robust insights and processes for supporting clients with Product License Applications and Compliance with Health Canada regulations.
Services and Solutions
We take a holistic view by taking into consideration your product development goals and the current regulatory and compliance environment whether going from concept to finished product or modifying a current formulation.
Preparation of evidence reports based on scientific literature searches, review and analysis that support the product’s health claim(s).
Safety Summary Reports
Preparation of Safety Summary Reports based on scientific literature searches, review and analysis.
Scientific and Clinical Studies Articles Review
Scrutiny and submission of full text articles of scientific and clinical studies supporting the product’s efficacy and safety.
Quality Summary Reports
Preparation of a Quality Summary report stating the final product specifications, including the identity, purity, potency and quantity of the medicinal ingredients, and describing the unit process operations and the in-process quality control points used during manufacture.
E-submissions for pertinent official product registration forms (product license application, NPN numbers)
An essential component of the Product License Application (PLA) submission to explain why combining ingredients at their respective quantities is likely to be safe and efficacious within the context of the recommended conditions of use.
Product License Applications (PLA)
We provide Product License Application (PLA) submissions services for the four classes of Natural Health Products. Each class of product has different requirements in terms of the information to be submitted at the time of review.
Licenses for products with a single ingredient that have well-known dosages and clinical indications.
For formulations that contain botanical ingredients. These formulations are well described in traditional herbal literature and have dosages and clinical indications that have been traditionally described. This classification will require Quality and Safety reports to be filed.
Formulations that have multi-ingredient combinations that may or may not be supported by modern clinical trial evidence efficacy claims. This classification requires Quality, Safety and Efficacy reports to be prepared and filed.
Homeopathic medicines are required to have product number before being sold in Canada. The product number appears on the label of the product preceded by DIN-HM. We assist in the completion and submission of the Product License Application (PLA) for specific claim applications and non-specific claim applications. along with evidence of safety and efficacy for review by Natural Health Products Directorate (NHPD) prior to Health Canada approval.