We Are Experts in Canadian Natural Health Product (NHP) Compliance
Helping NHP brands move from regulatory uncertainty to Canadian market entry.
In Canada, launching a NHP is not just about obtaining a Natural Product Number (NPN). Before a product is ready for market, brands need to understand how classification, formulation, claims, evidence, bilingual labelling, quality requirements, Site Licence (SL) obligations, and Health Canada expectations may affect the path forward.
Source Nutraceutical, Inc. (SNI) supports NHP brands with practical regulatory guidance across the full product lifecycle. From early market-entry planning to ongoing compliance, our team helps clients identify regulatory considerations, close documentation gaps, and move forward with greater clarity and confidence.
Strategy
Alignment
We help you understand Canadian requirements early and build a regulatory strategy that supports your business goals.
Claim
Support
We assess evidence expectations and help strengthen the scientific foundation for your formulation and health claims.
Comprehensive
Submissions
We help ensure your documentation, labelling, and quality systems meet Health Canada expectations.
Confident
Launch
We support you from submission to post-licence compliance so you can focus on growing your brand.
Canadian NHP Regulatory Experts You Can Rely On
Proven Canadian NHP Experience
2100+ Successful NHP Applications
Proven track record of advancing NHPs to successful market authorization.
20+ Years of NHP Consulting
Two decades of focused expertise developing and navigating Canada’s NHP regulatory landscape.
Multi-Divisional
Support
Integrated regulatory, scientific, strategic, and creative support across our specialized teams.
Our NHP Services:
Product Development and Regulatory Strategy
- Product development consulting and regulatory planning
- Regulatory feasibility assessments for new and reformulated products
- NHP classification support and Health Canada rulings
- Ingredient assessments, including novel and higher-risk ingredients
- Health claim validation and substantiation strategies
Product Licence Applications (PLAs) and Health Canada Submissions
- Preparation and submission of Product Licence Applications (PLAs)
- Support for monograph-based and evidence-based submissions
- Liaison with Health Canada throughout the review process
- Management of clarification requests and information requests
- NHP Master File development and maintenance
Clinical Evidence and Claim Substantiation
- NHP clinical trial strategy and protocol development
- Execution of human clinical trials to support health claims
- Alignment of clinical evidence with Health Canada requirements
Quality Assurance and Compliance Support
- Quality management system support aligned with NHP requirements
- GMP and Site Licence readiness assessments
- Support for manufacturers, packagers, labellers, and importers
- SOP development and review
- Document control and quality record support
- Internal audit support and inspection readiness
- Corrective and preventive action (CAPA) support
Site Licensing and Post-Market Compliance
- Site Licence support for manufacturers, packagers, labellers, and importers
- Post-market compliance and regulatory maintenance
- Label change assessments and ongoing regulatory support
How Our NHP Consulting Process Works
Step 1: Product Feasibility and Label Assessment
We review the formulation, ingredients, dosage form, proposed claims, label copy, call-outs, and packaging visuals against Canadian NHP requirements.
Step 2: Regulatory Pathway and Evidence Strategy
We define the appropriate licensing pathway, assess claim and evidence expectations, and align with the client on required formulation, label, or substantiation updates.
Step 3: Submission and Compliance Execution
Where needed, we prepare PLAs, support monograph-based or evidence-based submissions, refine compliant label text, and manage Health Canada communications.
Step 4: Post-Licence and Lifecycle Support
We support NPN maintenance, product updates, label changes, reformulations, SL readiness, GMP alignment, and ongoing compliance as your NHP portfolio evolves.
Not sure where to start?
Learn about the NHP requirements and regulations using some of our resources:
A Trusted Regulatory Partner for NHP Brands
NHP launches are strongest when regulatory strategy, compliant packaging, quality requirements, and market readiness move together. SNI works as an extension of your regulatory, innovation, and brand teams, helping you reduce compliance risk, accelerate commercialization, and build a scalable path to growth across Canada.
Book an introductory call using the following form: