Bordermark is a boutique regulatory consultancy for consumer health and wellness brands. We guide products through Health Canada and the U.S. FDA, from first licence to the day an enforcement notice lands.
Select a sector to see how we handle it in Canada and the United States.
From nutrition panels to ingredient legality, we make sure your food and beverage products can sit on a shelf in either country without inviting a recall.
Supplements and natural health products carry the heaviest claim and licensing burden. We take you from formulation to a licensed, market ready label.
Medical devices live or die on classification. We map your device to the right class and route in each market, then get you licensed to sell.
Cosmetics look low risk until a claim crosses into drug territory. We keep your ingredients, naming, and claims on the right side of the line.
Regulatory work is not only paperwork at launch. It is the notice that arrives eighteen months later. We cover the whole arc.
Natural Product Numbers, medical device licences, cosmetic notifications, and facility registrations, prepared filing ready for each market.
Every panel checked against the applicable regulation, returned as a clear deviation report your design team can act on.
Structure function, disease, nutrient content, and origin claims reviewed against the evidence bar each one must clear.
Response strategy for FDA Warning Letters, Untitled Letters, and Health Canada compliance notices, with a corrective action plan.
Support when product is detained or placed on an import alert, including remediation and petitions for removal.
Listing and A plus content compliance, Supplement Facts alignment, safety and cGMP documentation, plus takedown and ASIN reinstatement.
Recall classification support and adverse event and MedWatch reporting workflows so a small issue does not become a public one.
End to end review of a whole product line for launch or marketplace onboarding, handled as a single managed engagement.
Ongoing regulatory sign off across your catalogue at a fixed monthly fee, with priority turnaround as you launch and update.
Marketplace and agency enforcement now moves in weeks, not years. When a notice arrives, the response window is short and the wording of your reply matters. We help you answer it correctly and get back to selling.
Every engagement is priced up front, so you approve the deliverable and the cost before any work begins. There is no open hourly meter. Because category, market, and complexity vary so widely, we quote each project rather than post a fixed number.
A full review of one product against the rules of one target market.
End to end review of a full product line for launch or marketplace onboarding.
Continuous regulatory coverage as you launch, update, and defend your catalogue.
Prepare a filing ready dossier to license or notify a product in your target market.
A structured response when a notice, takedown, or detention lands.
Migrate a natural health product to the modernized Product Facts Table framework.
Every proposal is fixed scope and fixed price, sent in writing for your approval before work begins. Volume, urgency, and multi market work are reflected in the quote.
Amazon now treats your Supplement Facts panel as the single source of truth for your whole listing. When a page falls out of line, Amazon can suppress it, and a hidden listing earns nothing while the clock runs. Move the sliders to see what that looks like for a catalogue like yours.
Illustrative model. Based on reported cases where a suppressed supplement listing lost roughly its full daily revenue for every day it stayed hidden, plus a period of reduced ranking after it returned.
A short consultation to pin down your product, target markets, and the exact question in front of you.
We assess your files against current Health Canada and FDA requirements, citing every rule behind every finding.
A clear, prioritized deliverable your team can act on, with findings, fixes, and the path to compliance.
Revision included, plus the option to retain us for ongoing coverage as your catalogue grows.
Yes. Border fluency is the point of Bordermark. Most of our clients sell into both markets, so we review a product against Health Canada and FDA requirements in parallel and build a single label strategy that works on both sides.
Yes, and quickly. Enforcement response is a core capability. We assess the notice, build a corrective action plan, and prepare the response, whether that is a reply to an agency letter, an import alert remediation, or an Amazon reinstatement package. These matters run on short clocks, so reach out as soon as the notice arrives.
That is what the Catalogue Program is for. We review an entire product line across both markets as a single managed engagement, covering labels, listings, Supplement Facts alignment, and claims, with a consolidated tracker so nothing is missed at launch or marketplace onboarding.
Four: food and beverage, dietary supplements and natural health products, medical devices, and cosmetics. Each has its own licensing, labelling, and claim rules, and we work across all of them, so a multi category brand has one team rather than four.
Fixed scope, priced up front. You approve a defined deliverable and price before work begins, so there is no open ended hourly meter. Ongoing needs are handled through a monthly retained advisory arrangement. The pricing section shows typical starting points.
Share your product and target markets, and we will come back with scope and a fixed price. Facing a notice or a takedown already? Say so, and we will prioritize your reply.
We reply with scope, price, and an intake checklist. No obligation.