Regulatory Services

Full compliance support for every stage — from initial licensing to cross-border expansion. We handle the paperwork so you can focus on your products.

Site Licence

We prepare and submit your Site Licence application to Health Canada, ensuring full compliance with the Natural Health Products Regulations (NHPR). This is required for any facility that manufactures, packages, labels, or imports NHPs for sale in Canada.

Included in Starter

Natural Product Number (NPN)

Every natural health product sold in Canada must have a Natural Product Number (NPN) or a Drug Identification Number-Homeopathic (DIN-HM). We handle the entire application including evidence review, safety assessment, and labelling compliance. Review classes: Class I (single monograph, up to 60 days), Class II (2+ monographs, up to 90 days), Class III (full evidence review, up to 310 days).

Included in Starter

Quality Assurance Programme (QAP)

A QAP is mandatory for all NHP site licence holders. We design and document your quality assurance programme to meet Health Canada standards, covering raw material testing, in-process controls, finished product specifications, and stability testing.

Included in Starter

Labelling Compliance

NHP labels must include specific information: product name, NPN, dosage, medicinal and non-medicinal ingredients, claims, warnings, and more. We review and certify your labels before they go to print.

Included in Starter

Importation Services

Importing NHPs requires a valid Site Licence, proper documentation, and compliance with Canada Border Services Agency requirements. We manage the entire importation process including permits, customs documentation, and regulatory clearance.

Included in Starter

US Agent & FSVP

Selling supplements in the US requires a US Agent for foreign facilities and compliance with the Foreign Supplier Verification Program (FSVP). We provide registered US Agent services and handle all FSVP documentation and requirements.

Included in Starter

Product Liability Insurance

Protect your business with product liability insurance that covers manufacturing defects, improper labelling, and contamination claims. Starter tier and above includes comprehensive coverage tailored to the NHP industry.

Included in Starter
Competitive Advantage

Ready for Health Canada's 2028 Product Facts Table

Health Canada is transitioning to the Product Facts Table (PFT) format for all natural health product labels by 2028. Our Product Licence wizard already generates compliant PFT labels — so your products will be ready while competitors scramble to update theirs.

PFT-Ready
Auto-generated labels
LiquidFiles
Secure document transfer
Zero Disruption
Compliant from Day 1