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Commercialization &
AI Compliance for Life Sciences

Regulatory-Safe Market Access | GTM | AI Automation | Operational Efficiency

Your Competitive Advantage

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Strategic Growth AI helps pharma, biotech, AI-health, MedTech, diagnostics, and digital health companies commercialize, scale, adopt, and automate compliant AI solutions across Canada, the U.S., and the EU.

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Audit Assurance + Strategic Velocity

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We align regulatory strategy, market access, patient support programs (PSPs), and field execution, so launches clear reviews faster and keep performing post-approval.

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AI Governance Built In

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Our auditable AI workflows embed industry codes (IMC, PhRMA), regulatory requirements (Health Canada, FDA, PMPRB), and privacy rules (HIPAA, PIPEDA, GDPR) with full traceability and regulatory-grade documentation.

 

The Result:
✓ Faster, compliant launches
✓ Real-time adaptation to regulatory updates
✓ Trusted intelligence for any challenges
✓ Reduced manual effort, fewer errors
✓ More capacity for client engagement

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Adapting to regulatory change at speed isn’t optional, it’s your competitive edge.

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Grow Faster. Stay Compliant

Commercialization & Access

Go-to-market (GTM) strategies that align with key reimbursement guidelines PMPRB rules, CDA-AMC (CADTH) and pCPA negotiations; U.S. CMS 2026 (fee schedule) and industry codes (IMC, PhRMA, Sunshine Act).

 

Includes handling U.S. state-by-state payer and health maintenance organization (HMO)

Regulatory & Evidence

Regulatory submissions and real-world evidence packages designed to meet standards from Health Canada, FDA, EU health technology assessments and EU regulators.

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With built-in data tracking, fair claims, ready-for-audit docs, and EU privacy rules (GDPR and CNIL integration), 

Regulatory-Safe AI Workflows

Automated systems that incorporate privacy protections (U.S. HIPAA cybersecurity enhancements, Canada's PIPEDA data mobility updates, EU/France GDPR and CNIL guidelines for AI deployments).

 

Promotional standards (IMC/PAAb/PhRMA), transparency reporting (Sunshine Act/IMC), and U.S. state-level rules

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Why Teams Choose Us

  • Combined Industry Experience: 40+ yrs, 100+ launches

  • Regulatory-first: Built to survive IMC, MLR, Health Canada / FDA, and payer review

  • AI with guardrails: Regulatory-safe automations that are auditable and integrated with your tech stack

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View the evidence

Our Approach

We work with AI-health, pharma, biotech, medtech, specialty pharmacies and diagnostics companies, as well as medical clinics and PSP providers.

 

We also support healthtech accelerators and investors who need regulatory-safe, evidence-based commercialization for their portfolios.​​

60 to 80%

Lower operational cost

in admin-heavy workflows

30% 

Improvement in budget accuracy with investor-grade, risk-adjusted models

 Compliance by Design

Every action traceable for regulators, payers, and MLR

Regulatory Safe Automations

Compliance PromoGuard™

​For: Commercial and Regulatory teams in Pharma, Biotech, and MedTech

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Solves: The "velocity crisis" caused by MLR (Medical, Legal, Regulatory) bottlenecks, reviewer burnout from repetitive errors, and slow time-to-market.

  • Ingests promotional assets (PDF, DOCX) from Veeva or Adobe via API for immediate parsing.

  • AI agents cross-reference claims against the Product Monograph and audit content against the IMC/PhRMA Code for prohibited words or tone.

  • Generates "remediation" suggestions to fix non-compliant text before human review.

  • Enterprise security with strict security guardrails

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 Commercial Intelligence & AI Governance Hub

For: CIOs, CTOs, and Country General Managers

 

Solves: "Black box" AI risks (hallucinations), data silos, and a lack of operational visibility across the commercial engine.

  • Enforces "Constitutional AI" guardrails and mandates Human-in-the-Loop (HITL) for high-stakes decisions.

  • Ingests data from all other service containers to visualize bottlenecks (e.g., "Legal is delaying MLR").

  • Suggests operational fixes rather than just sales actions to improve velocity.

 

Result: De-risked AI adoption, real-time operational visibility, and improved decision velocity.

Automation Examples

Customized AI Automation Available

Field Force Event Shield

For: Sales Reps, District Managers, Commercial Ops

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Solves: The risk of accidental non-compliance, reputational optics (e.g., inappropriate venues), and wasted time manually checking FMV and IMC limits.

  • Protective Pre-Clearance: Uses a “Zero Trust” model to validate all logistics (venue, guest list, cost) before spend, preventing errors and audit issues.

  • Venue Safety Agent: Flags high-risk venues (e.g., spas, resorts, casinos) so reps avoid triggering IMC scrutiny over “lavish” locations.

  • Spend Guardrails: Auto-calculates per-head cost vs. FMV caps, eliminating manual tracking and ensuring “modest and incidental” thresholds are met.

 

Result: A pocket compliance officer that prevents non-compliant spend in real time—ensuring 100% venue and meal adherence, zero enforcement surprises, and reclaimed rep time.

Specialty Pharmacy & Patient Access Hub

For: Specialty Pharmacies, Patient Services, and Market Access teams

 

Solves: High patient abandonment rates, manual prior authorization (PA) delays, and the administrative burden of fax-based workflows.

  • Intelligent Intake agent OCRs incoming fax enrollment forms and instantly flags missing data.

  • Connects to payer portals to automate Benefit Verification and Prior Authorization using clinical evidence from the EHR.

  • Generates customized appeal letters citing clinical guidelines if a PA is denied.

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Medical Affairs & Grant Governance Platform

For: Medical Affairs Directors and Grant Committees

 

Solves: The risk of "quid pro quo" allegations, lack of separation between Commercial and Medical, and "pay and forget" grant mismanagement.

  • Enforces a strict digital firewall where Commercial can submit requests but is blocked from approval workflows.

  • Tracks grant milestones (e.g., "First Patient In") and releases payments only upon verification.

  • Monitors sample chain-of-custody to detect stockpiling anomalies.

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Global Transparency Automation Suite

For: Finance and Compliance teams managing Sunshine Act/IMC reporting

 

Solves: Data fragmentation across ERP/Expense systems, manual reconciliation errors, and the risk of inaccurate public reporting.

  • Ingests and cleanses data from SAP, Concur, and CRO portals into a unified source of truth.

  • Uses "Identity Resolution" to map disparate records to unique HCP identifiers (NPI/License).

  • Classifies transactions (e.g., consulting vs. meals) and offers a pre-disclosure portal for HCP dispute resolution.

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Automate. De-Risk. Grow.

Our Services:

  • Cut admin workload by 60–80% in clinics and PSPs

  • Accelerate launches by 3–6 months with investor-grade, risk-adjusted forecasting

  • Turn decisions into Monte Carlo, rNPV, IRR scenarios your board actually understands

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Built to Fit Your World

  • System Integration
    Plugs into your existing stack (Veeva, Snowflake, EMR, CRM), so you get orchestration, not another disconnected tool

  • IMC, HIPAA, GDPR, and data residency baked into every workflow, with full audit trails

  • Training & Support​

Lets Talk

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​We’ll identify where targeted support can remove your biggest cost and risk drivers, boost efficiency and ROI, and improve both client and team satisfaction.​

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