De-risk your U.S. and Canada launch
De-risk your U.S. and Canada launch before you commit capital, as 62% of life sciences launches underperform Wall Street expectations. Most fail not because of the science, but because they treat market entry as a sequence: regulatory first, reimbursement later, commercial last.
At Strategic Growth AI, we know that in today’s capital-constrained environment, you can’t afford that delay. We run regulatory, market access, and go-to-market in parallel, starting 12–18 months before launch, so your dossier is built to satisfy both Health Canada/FDA and payers from day one.
Why this matters:
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In Canada, Health Canada approval doesn’t guarantee CADTH recommendation or provincial reimbursement. Without early alignment, you win a license but not a market.
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In the U.S., FDA clearance is necessary but not sufficient. CMS, Medicare Advantage plans, and PBMs demand real-world evidence, economic value, and clear coding, often before they’ll pay.
Our approach is different because it’s integrated and investor-grade:
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We design your clinical and regulatory strategy to generate dual-purpose evidence: for regulators and for CADTH/pCPA or AMCP dossiers.
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We activate commercial infrastructure as approvals close, provincial negotiations (Canada), PBM/IDN contracts (U.S.), specialty pharmacy workflows, and field teams with real-time access intelligence.
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We embed growth levers early, like RWE for pricing defense or indication expansion, so your launch doesn’t plateau in year one.
The result:
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60 percentage point lower launch failure risk
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10–30% faster time to paid claims
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A milestone-driven roadmap that protects valuation and aligns with investor expectations
We serve biotech, pharma, medtech, diagnostics, SaMD, and AI-health innovators, from Seed to Series C—and the investors who back them. Unlike generalist firms, we’re operators who’ve secured FDA/Health Canada approvals, led pCPA negotiations, and built go-to-market engines that deliver.
Because in North America, success isn’t about getting approved. It’s about getting paid.