← Market entry

Launch in the USA

Define your FDA pathway, prepare the submission and put US agent and establishment obligations in place.

FDA4-9 months typicalUS Agent
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Requirements

What launching in United States takes.

01Pathway determination (510(k), De Novo, PMA, OTC monograph)
02Predicate and precedent analysis
03Submission dossier preparation
04Establishment registration and product listing
05US Agent appointment
06Labelling and claims compliance review
Related services

Standalone services for United States.

Regulatory Strategy
Regulatory Strategy Assessment

Pathway options, precedent review and a recommended route to market.

Other markets

Launching somewhere else?

Launch in the UKLaunch in the EULaunch in the GCCLaunch in Saudi ArabiaLaunch in IndiaLaunch in SingaporeLaunch across ASEAN

Ready to launch in United States?

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