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Quality Smart Solutions (QSS) works with health product companies across North America and beyond; from dietary supplements and functional foods to medical devices, cosmetics, pet products and pharmaceuticals. Whatever your product category, we know the regulatory landscape and how to navigate it.
Every health product category comes with its own regulatory framework, timelines, and requirements. QSS brings deep expertise across each one, so you get guidance that's specific to your product, not generic compliance advice.
NPN licensing, product submissions, label compliance, and formula development under Health Canada's NHP framework.
FDA compliance for supplement manufacturers and brands, including facility registration, NDINs, and Supplement Facts panels.
GRAS notifications, self-affirmed GRAS, NDI notifications, and novel food pathways for ingredient suppliers and biotech companies.
End-to-end food compliance across Health Canada and FDA, including labelling, novel food, SFCR licensing, HACCP, and facility audits.
Device licensing, 510(k), MDEL, and SaMD pathways across Canada and the U.S. for manufacturers and importers.
MoCRA compliance, facility registration, label review, and safety substantiation for cosmetic brands in Canada and the U.S.
DIN applications, drug establishment licensing, and NDS/ANDS submissions for OTC drug companies operating in Canada.
NPN licensing, label compliance, and product submissions for homeopathic medicine companies navigating Health Canada requirements.
Regulatory support for veterinary health product companies, including product licensing and compliance across Canadian and U.S. frameworks.
Federal licensing, regulatory compliance, and advisory support for cannabis companies operating under Health Canada's framework.
Our regulatory compliance solutions don’t stop at the Canadian or U.S. border. Whether you’re expanding into Europe, the UK, Asia, or Latin America, QSS has the expertise and the network to support your global market entry. We work with health product companies navigating international frameworks alongside their North American compliance requirements, so your regulatory strategy stays aligned across every market you operate in.
Many regulatory consultants specialise in only one or a few areas. Quality Smart Solutions (QSS) works across the full spectrum of health product categories, from NHPs and dietary supplements to medical devices, food and beverage, cosmetics, and beyond. That breadth means you’re never handed off to someone else when your business grows, and you’re never starting from scratch with a new team every time your product portfolio expands.
Since 2007, QSS has helped 3,500+ companies across 74 countries navigate Health Canada, FDA, and global regulatory requirements. Our team brings hands-on experience across every vertical we work in, and we connect compliance decisions to the commercial realities of your business. Whether you’re a growing brand navigating your first product submission or an established company managing a complex, multi-market portfolio, we bring the same level of depth and attention to every engagement
Regulatory classification isn't always straightforward. Some products sit at the intersection of two or more categories, and the wrong classification can affect your timeline, your labelling, and your path to market. QSS has helped 3,500+ companies across every major health product category find the right regulatory pathway, and we can help you do the same.
Talk to a specialist about your SaMD compliance pathway — whether you are determining classification for the first time or preparing a submission for the U.S. market.