From foreign entity to U.S. operating presence in 90 days.
International life-science companies entering the U.S. market face a specific set of obstacles: entity structure, FDA strategy, payer landscape, and commercial infrastructure. We have built a program that addresses all of them in sequence.
90 days. One integrated team.
Most market entry engagements are advisory. A consultant produces a report; the client figures out implementation. Our program is operational. We stand up the entity, open the bank accounts, file the FDA registrations, and introduce the commercial relationships.
TAMP Clinical handles the regulatory and clinical components. The rest of the infrastructure — legal, financial, commercial — comes from our partner network in Kendall Square.
Three phases, one outcome
Entity and infrastructure
U.S. legal entity formation, EIN, bank accounts, registered agent, and initial compliance filings. Office address in Cambridge, MA if needed.
Regulatory and clinical positioning
FDA establishment registration, product classification, pre-submission strategy, and IND or 510(k) pathway determination. Clinical trial readiness assessment if applicable.
Commercial and payer infrastructure
Payer landscape analysis, reimbursement strategy, KOL introductions, and commercial partnership identification. Boston-area investor and partner introductions where appropriate.
Built for companies at a specific moment.
This program is designed for international life-science companies — device, diagnostic, pharmaceutical, or digital health — that have a validated product and are ready to enter the U.S. market. It is not a feasibility study. It is an execution program.
CE-marked device companies seeking FDA clearance
European pharma companies planning U.S. IND filings
Digital health companies with EU approval seeking FDA De Novo
Diagnostics companies navigating CLIA and FDA LDT rules
Any company that needs a U.S. operating presence, not just a strategy deck
Based at the center of the ecosystem.
Our address at 1 Kendall Square, Cambridge, MA is deliberate. Kendall Square is the densest concentration of life-science innovation in the world. For international companies entering the U.S. market, a Cambridge address is not just an address. It is a signal.
1 Kendall Square, Cambridge, MA 02142
Ready to enter the U.S. market?
The program starts with a single conversation. David Hall leads every engagement personally.