01, Market Entry

Choose where you want to launch.

We take regulated products from one market into another, pathway definition, registration, local representation, launch readiness and ongoing support.

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Launch programmes

Market-entry programmes by country.

Each programme covers the requirements, representation and submissions specific to that market.

Europe
Launch in the UK

MHRA

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North America
Launch in the USA

FDA

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Europe
Launch in the EU

Notified Bodies / EMA / National Authorities

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Middle East
Launch in the GCC

SFDA, MOHAP, GHC and national authorities

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Middle East
Launch in Saudi Arabia

SFDA

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South Asia
Launch in India

CDSCO

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ASEAN
Launch in Singapore

HSA

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ASEAN
Launch across ASEAN

HSA, NPRA, FDA PH, Thai FDA, MOH VN, BPOM

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Scope

What a market-entry programme covers.

Programmes are scoped to your product, target market and existing documentation.

01Regulatory pathway assessment
02Product classification
03Market-specific requirements
04Documentation
05Product registration
06Submissions
07Local regulatory representation
08Labelling
09Compliance
10Launch readiness
11Ongoing regulatory support
Inside the platform

See what each market requires.

Readiness scoring, open requirements and the next actions needed to unlock a market.

Prioritised regulatory next actions for the EU inside the Regulatory Passport platform
A prioritised action list, sourced from verified regulatory frameworks.