Our Services

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We help clients bring safe, compliant NHPs and foods to market in Canada and dietary supplements in the U.S. Services Include:

Health Canada Product Licence Applications and Site Licences

FDA Dietary Supplement Establishment Registration and notifications

Label compliance (English & French)

Structure/Function notifications

Ingredient and formulation reviews

Full regulatory support for cosmetic products in both Canada and the United States. Services Include:

Health Canada Cosmetic Notification and compliance

FDA MOCRA facility registration and cosmetic compliance

Ingredient assessments and labelling requirements

Safety documentation and advertising review

Specialized consulting for OTC drug products across North America. Services Include:

Health Canada OTC Drug identification numbers and registrations

FDA OTC monograph compliance and new drug applications

Labelling, claims, and packaging requirements

Post-market reporting obligations

End-to-end regulatory services for medical device manufacturers. Services Include:

Health Canada Medical Device Licence applications (Class I–III)

FDA 510(k), De Novo, and Establishment Registration

Technical documentation and quality system requirements

Post-market surveillance and vigilance reporting

Building and maintaining robust quality systems for long-term compliance. Services Include:

GMP / QMS development and implementation

Site licence applications and establishment registrations

Internal audits, gap analysis, and corrective actions

SOP development and staff training

Ongoing compliance support for both Canadian and U.S. requirements

 We support a wide range of additional regulatory and quality needs across Canada, the United States, and international markets. This includes cross-border strategies, import/export compliance, international registrations, specialized audits, training programs, and custom projects not covered in standard categories. If your needs are unique, we’ll develop a tailored solution.