In Canada, most nutraceuticals are regulated as natural health products under the Natural Health Products Regulations. Sites that manufacture, package, label, or import NHPs need a site licence and must meet the GMP requirements set out in Part 3 of the Regulations, and Health Canada has been increasing its GMP compliance monitoring of NHP sites.
Meeting those expectations is as much an engineering problem as a paperwork one. Equipment has to be specified, installed, and qualified correctly. Cleaning has to be shown to work. Material and personnel flow has to make sense, and labeling and packaging lines have to run reliably at speed.
Our nutraceutical GMP consulting brings pharmaceutical-grade qualification discipline to NHP operations, scaled to the size of your site and the risk of your products.
Scoped to your products, your site, and what Health Canada will look for.
We help you through the site licence process, preparing the facility, equipment, and GMP evidence your application and inspection depend on.
Specification, factory and site acceptance testing, and IQ/OQ/PQ for nutraceutical process and packaging equipment.
Cleaning programs that can be demonstrated, not just written, for shared multi-product equipment.
New builds, expansions, and room conversions designed for compliant, efficient flow.
Packaging line engineering, labeling verification, and serialization where it is required.
Quality systems sized for nutraceutical operations, and support when an inspection is on the calendar.
Capsules, tablets, softgels, powders, liquids, and stick packs, from blending and encapsulation through bottling, labeling, and final packaging. Our team’s background is in pharmaceutical manufacturing, so NHP clients get the same qualification rigor applied with sensible, risk-based scope.
We are based in London, Ontario and support NHP manufacturers across the Greater Toronto Area, Southwestern Ontario, and the rest of Canada, with on-site work by arrangement.
We review your process, equipment list, timelines, and regulatory drivers, and agree on what a finished deliverable looks like.
A fixed-scope proposal or embedded-support plan, with the validation approach, deliverables, and milestones set out before work starts.
Our engineers write and execute protocols, documentation, and engineering packages alongside your operations and quality teams.
Summary reports, deviations resolved, and a documentation package your quality unit can approve and an inspector can follow.
Tell us what you make and where you are in the process. We will respond with a practical next step.
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