Free one-page guide
The U.S. Market Entry Playbook.
For life-science companies bringing a medicine to the United States: ten key steps, and the pitfalls that slow companies down.
What's inside
- Define the U.S. ambition and timeline
- Map the regulatory and compliance path, with qualified partners
- Set up the legal entity, tax and IP
- Treat the U.S. as many markets, and prioritize
- Build the value story, pricing and access
- Choose the route to market
- Hire the U.S. team in the right sequence
- Build local evidence and references
- Sequence the launch with a 100-day plan
- Design governance with headquarters
Plus the most common pitfalls, from underestimating access and reimbursement to slow decisions between headquarters and the U.S. team.
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General guidance only, not legal, regulatory or tax advice. FDA and other regulatory work should be handled with qualified regulatory partners.
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Read the full article
The thinking behind the playbook, step by step.
Entering the U.S. market: a playbook for overseas healthcare companies
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