Market Entry & Launch (Can & US)
Enter Canada and the U.S. without the guesswork. We run Health Canada/FDA, market access, and GTM in parallel, so you move from regulatory to revenue with fewer surprises.
Who we help
Biotech, Pharma, MedTech, Medical Device, Diagnostics, and SaMD, AI-health, from Seed to Series C, SMB units, enterprise BUs, and investors that need operator-grade execution.
Integrated Commercialization for Canada and the United States
We are a cross-border partner purpose-built to take life-science innovations from dossier to durable revenue in North America. Our model unites regulatory strategy, market access, distribution infrastructure, and omnichannel engagement in one integrated approach, so regulatory approval becomes payer access, and access becomes sustained adoption.
1) Cross-Border Commercialization Framework
Build → Run → Scale under a single governance model, adapted to Health Canada and FDA realities.
Build
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Pathways and dossiers.
Canada: DIN/NDS for drugs; Medical Device Classes II–IV with MDEL; SaMD under Health Canada guidance.
United States: IND → NDA/BLA for drugs/biologics; 510(k)/De Novo/PMA for devices and IVDs. -
Safety, quality, and labelling/labeling.
Pharmacovigilance and QMS; bilingual labelling in Canada; DIN assignment (Canada); DSCSA serialization for U.S. drugs; UDI for devices. -
Early pricing guardrails.
PMPRB corridor (Canada); Best Price/ASP triggers (U.S.); principles for value-based agreements. -
Coding and evidence plans.
CADTH/INESSS requirements and pCPA dossier (Canada).
AMCP Format v4.x, HCPCS/CPT/J-code narratives, and CMS policy mapping (U.S.).
Run
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Manage submissions, label negotiations, PV activation, and post-approval commitments.
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Advance pCPA strategy and provincial listings (Canada); secure PBM and IDN contracts (U.S.).
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Activate SP/hub workflows (benefit verification, prior authorization, adherence).
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Enable field teams with up-to-date formulary and PA status; deploy targeted omnichannel launch programs.
Scale
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Expand indications, SKUs, and geographies; use RWE for pricing defense and access upgrades.
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Add service layers where appropriate (e.g., companion Dx/DTx, adherence support).
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Optimize gross-to-net through disciplined rebate/chargeback controls and contract true-ups.
Continuous safeguards PAAB/MLR, PV signal detection, EN/FR labelling (Canada), cold-chain validation, SaMD controls (MDSAP/IEC 62304/82304; PCCP), GTN compliance, and Québec/Indigenous localization operate from day one.
2) Market Access & Reimbursement
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Engage payer and HTA advisors early to close evidence gaps before submission.
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Produce best-practice dossiers: CADTH/INESSS core with province-specific budget-impact addenda; AMCP/P&T decks tailored to national plans, PBMs, and IDNs.
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Use negotiation analytics to inform pCPA strike-zones and U.S. value-based structures.
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Embed rebate and chargeback validation within GTN controls to protect Best Price and inform field pull-through.
KPIs: coverage depth, tiering, PA cycle time, net-price protection, GTN variance.
3) Go-to-Market & Growth
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Align one scientific and economic narrative, pressure-tested with payers, prescribers, and patients.
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Run data-driven ICP segmentation; provide digital air cover ahead of field engagement; deploy the right mix of KAMs, MSLs, nurse educators, and reimbursement case managers.
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Use scenario-based pricing and packaging (annuity, milestone, subscription, shared-savings) and growth levers (indication stacking, geographic expansion, Dx/DTx companions, and service bundles).
Sector-Specific Playbooks
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Pharma: NDS/NDA; S-NDS/PAS. Competitive HEOR, KOL activation, and lifecycle strategies.
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Biotech/ATMP: BTD/RMAT; NOC/c (Canada). Outcomes-based models, cryogenic 3PL, and center-of-excellence targeting.
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Rare/Orphan: Orphan designation; priority review pathways; evidence co-creation, genomic-testing partnerships, and advocacy coalitions.
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MedTech: 510(k)/De Novo/PMA; MDEL (Canada). IDN economics, capital-plus-consumable bundles, ASP strategy and NTAP (inpatient) where applicable.
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Diagnostics/IVD: 510(k) + CLIA (U.S.); Health Canada IVD pathways. PLA/MAAA coding, lab-channel KOLs, clinical-utility proof points.
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Digital Health/AI (SaMD/DTx): SaMD guidance; PCCP for algorithm change control; RTM billing options; employer and plan contracts.
Governance & Engagement
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Cadence: agile sprints, executive reviews, and board-level steering with red/amber/green dashboards.
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Models: Complete Commercialization Partnership (turnkey), Build-Run-Transfer, Operator-of-Record under SLAs, or Hybrid Governance.
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Why us: Integrated North-American execution from regulatory to distribution; protection of asset ownership (no forced licensing); AI-enabled planning; unified patient-journey insights.
Let’s turn your next approval into durable market adoption.