The American market is the largest prize in life science. It is also the hardest to crack. Regulatory pathways are opaque, and most foreign companies discover what they do not know only after it has cost them dearly.
Most companies entering America hire half a dozen separate firms: a regulatory consultant, a trade lawyer, a strategy shop, a BD person, a recruiter, and an accountant. The result is overlapping scopes, contradictory advice, and nobody accountable for the outcome. Arcstone replaces that entire stack with a single integrated team that runs operations efficiently using AI.
How the world's most innovative companies enter the American market faster
Embedded fractional CEO and COO. Entity formation through first revenue. AI compresses six-month buildouts into weeks. The full operation, built and run until you are ready.
FDA pathway planning, compliance architecture, reimbursement strategy. Customs classification, tariff navigation, and import logistics built in from day one. AI-powered regulatory intelligence maps the optimal pathway in days, not months.
Site feasibility, CRO selection, enrollment strategy, and trial management. AI-driven site scoring and predictive enrollment analytics replace the guesswork traditional CROs charge a premium for.
Distribution agreements, licensing deals, KOL networks. An agentic platform scans deal flow, patent filings, and corporate disclosures daily to surface targets and competitive signals. A living deal book, not a static deck.
Market sizing, positioning, pricing, channel design, launch operations. AI-generated market models and automated competitive benchmarking replace the twelve-week strategy engagement. We deliver the plan, then run it.
Traditional consultancies bill by the hour and staff by the head. We do neither. Arcstone charges flat retainers tied to milestones and outcomes. Our AI-native infrastructure means fewer people producing more work, faster. A five-person Arcstone team operates like twenty, at a fraction of the cost. That is not a tagline. It is the operating model.
time saved to pre-IND submission
Asia Pacific Biotech — US EntryAI-driven regulatory intelligence identified the optimal IND pathway, automated pre-clinical gap analysis, and generated submission-ready documentation in weeks — cutting the pre-IND timeline by more than half compared to the same company’s previous US filing.
Pre-IND meeting secured ahead of schedule.
to commercial launch
European Medical Device — US Entry and Pre-CommercialEntity formation, 510(k) regulatory strategy, reimbursement mapping, distribution agreements, and a full go-to-market operation built in parallel.
First US purchase orders within five months of engagement.