
Markets / Access Strategy
Kompete helps supplement, wellness, life sciences and
pharmaceutical brands navigate regulatory pathways
across North America, Europe, Australia, and key
international markets.
Strategic guidance across major health authorities, market-entry pathways, claims frameworks, and product classification systems.
Jurisdictions
Each market decides for itself what your product is, what it may contain and what you may say about it.
Canada / NPN Strategy
Navigate NPN pathways, evidence requirements, ingredient status, claims boundaries, and Health Canada expectations before formulation or launch decisions lock in.
United States / FDA Positioning
Clarify supplement positioning, claims risk, DSHEA considerations, label strategy, and commercialization assumptions for the U.S. market.
European Union / EFSA & EU Strategy
Assess classification, permitted claims, ingredient restrictions, member-state considerations, and the practical implications of EFSA-aligned expectations.
United Kingdom
GB novel foods, the GB claims register, and the labelling divergence between Great Britain and Northern Ireland.
Australia / TGA Pathways
Evaluate complementary medicine pathways, ingredient suitability, evidence expectations, claims framing, and readiness for TGA-aligned market entry.
China
SAMR health food registration, filing, and the cross-border e-commerce route into the mainland.
Japan
Foods with Function Claims notification and FOSHU approval, with substantiation published for public scrutiny.
India
FSSAI nutraceutical categories, permitted ingredient schedules, and central licensing for imported product.
Frameworks
Some products fall outside the main pathway in a market they are already sold in, under rules that are separate rather than additional.
Supplemented Foods (Canada)
Canada’s supplemented foods framework: permitted actives, the caution identifier, and NPN transition.
Channels
A platform can impose its own requirements regardless of whether the product is lawfully marketable.
Amazon Compliance
Marketplace documentation, restricted ingredients, claim review, and reinstatement of suppressed listings.
A smarter path to launch
01
Classify the product
02
Screen the formula
03
Build the roadmap
04

