Kompete Consulting signage in the office corridor

Markets / Access Strategy

Market access without the guesswork.

Market access without the guesswork.

Kompete helps supplement, wellness, life sciences and

pharmaceutical brands navigate regulatory pathways

across North America, Europe, Australia, and key

international markets.

Global regulatory coverage

Global regulatory coverage

Strategic guidance across major health authorities, market-entry pathways, claims frameworks, and product classification systems.

Jurisdictions

Where the product is authorised.

Where the product is authorised.

Where the product is authorised.

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

A different regime in the same country.

A different regime in the same country.

A different regime in the same country.

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

Rules that sit on top of the law.

Rules that sit on top of the law.

Rules that sit on top of the law.

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

Prepare for commercialization