Commercialization &
Compliance AI for Life Sciences

Regulatory safe market access, GTM, AI automation and operational efficiency

Commercialization & Compliance Automation Partner

Strategic Growth AI helps pharma, biotech, AI-health, medtech, and diagnostics companies commercialize, scale, and stay compliant in Canada and the U.S.

We align regulatory strategy, market access, PSP design, and field execution so launches don’t stall in reviews and keep performing after approval.

Our governed, auditable AI workflows embed IMC, PhRMA, Health Canada, FDA, PMPRB, HIPAA, and PIPEDA requirements with full traceability and regulatory-grade documentation.

The result:

Faster, compliant launches and scaling
Stronger regulatory adherence
Embedded intelligence
Fewer manual checks and errors
More time for client-facing activities

Grow Faster. Stay Compliant

Commercialization & Access

GTM strategies aligned with reimbursement rules (PMPRB, CADTH, pCPA, CMS) and commercial conduct codes (IMC, PhRMA, Sunshine Act). so pricing, messaging, and field activities stay compliant from launch onward

Regulatory & Evidence

Submissions and real-world evidence dossiers built to satisfy Health Canada, FDA, and HTA bodies with traceable data, balanced claims, and audit-ready documentation

Regulatory-safe AI workflows

Automated workflows that embed privacy (HIPAA/PIPEDA), promotional (IMC/PhRMA), and transparency (Sunshine/IMC reporting) rules, so every action, message, and dollar spent is defensible by design.

Why Teams Choose Us

Operator-led: 17+ years, 40+ 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

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

We don’t just automate workflows

We embed Company, Industry, HIPAA, PIPEDA, SOC 2, Provincial, State, Health Canada, and FDA compliance and more into every step.

Every automation is built regulatory-safe by design, auditable, encrypted, and integrated with your existing proprietary systems so you get results without disruption.

AI Automation Example

Patient Prescription Reminders
Detect → Process → Act

Part 1:

Schedule Creation → Triggered by “sent prescriptions”

Part 2:

Send Reminders → Time-based (every 10 mins)

Works seamlessly with your existing systems, no disruption, just results

Let’s book a 30-minute pilot scoping call and turn one of these into your first measurable ROI win.

Book a Call

Automation built on HIPAA, PIPEDA, SOC 2, FDA & Health Canada Compliance by Design.

Scheduling workflow for SGAI example.png

Compliance PromoGuard™

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

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.

Result: 30% reduction in MLR cycle time, 25% decrease in rework loops, and 10-15 FTE hours saved per week.

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

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.

Result: 40% reduction in time-to-therapy, 50% reduction in manual admin work, and 15% reduction in patient abandonment.

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.

Result: Full audit readiness, 30% faster grant processing, and safeguarding of scientific integrity.

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.

Result: 50% reduction in reporting man-hours, 95% reduction in reconciliation errors, and 100% on-time submission.

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

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

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.

Commercialization & Compliance AI for Life Sciences