Natural Health Product (NHP) Regulatory Consulting Services in Canada
Helping Natural Health Product brands successfully enter and grow in the Canadian market since 2004.
In Canada, dietary supplements are regulated as Natural Health Products (NHPs) and must comply with strict requirements administered by Health Canada. Before an NHP can be sold, it must obtain a Product Licence resulting in a Natural Product Number (NPN), and companies involved in manufacturing, packaging, labelling, or importing must hold a valid Site Licence.
Navigating these requirements can be complex. Our Regulatory Affairs team provides end-to-end NHP regulatory consulting services to help brands achieve compliance efficiently, reduce regulatory risk, and bring products to market with confidence.
Canadian NHP Regulatory Experts You Can Rely On
SNI combines regulatory consulting with deep industry experience to translate Health Canada requirements into practical, market-ready strategies. With more than 20 years of industry legacy and over 100 years of combined regulatory, clinical, and subject-matter expertise, our team helps NHP brands balance safety, efficacy, and product innovation while preparing for successful entry into the Canadian market.
As health-conscious Canadians increasingly turn to NHPs to support wellness and preventative care, regulatory scrutiny continues to rise. Health Canada requires that NHPs be demonstrated to be safe, effective, and of high quality, with appropriate evidence to support ingredients and health claims.
Our consultants work closely with clients to interpret regulatory requirements, align formulations and claims with Health Canada expectations, and manage regulatory submissions from start to finish.
We support a broad range of NHP categories, including products containing:
- Vitamins and minerals
- Herbal and botanical ingredients, including extracts and isolates
- Probiotics
- Amino acids, enzymes, and essential fatty acids
- Homeopathic medicines
- Traditional medicines, including Traditional Chinese Medicine (TCM) and Ayurvedic medicines
- Other naturally derived substances permitted for use in NHPs
Our Canadian NHP Regulatory Services
We provide strategic, practical regulatory support across the full NHP product lifecycle.
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: Discovery and Feasibility:
We assess your formulation, ingredients, claims, and regulatory pathway to confirm feasibility before submission.
Step 2: Regulatory Strategy and Preparation:
We define the optimal submission approach, including evidence requirements, claim alignment, and licensing strategy.
Step 3: Submission and Health Canada Liaison:
We prepare and submit your PLA and manage all communications with Health Canada on your behalf.
Step 4: Post-Licence and Lifecycle Support:
We support ongoing compliance, product updates, and regulatory maintenance as your product portfolio evolves.
A Trusted Regulatory Partner for Canadian Market Entry
Because branding and consumer trust are critical in the NHP space, our regulatory specialists collaborate closely with our creative and graphics teams to ensure labels and packaging are both regulatorily compliant and commercially effective.
Whether you are launching your first NHP in Canada or expanding an established product line, we provide the regulatory clarity, strategic guidance, and execution needed to move forward with confidence.
