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

Tell us where your product is going.

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