Commercialization &
AI Compliance for Life Sciences

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

Your Competitive Advantage

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.

Audit Assurance + Strategic Velocity

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

AI Governance Built In

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

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

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.

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

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

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.

All processing occurs in the client’s secure environment.

StrategicGrowthAI.com does not access or store client promotional assets, Product Monographs, or internal data.

AI Automation Example

Compliance PromoGuard™

Ingest → Analyze → Route

Part 1:
Marketing Content Ingestion → Triggered by a new asset upload

Part 2:
AI Analysis + Code Check → IMC/PhRMA rules, sentiment scan, stakeholder flagging

Review Routing → Auto-pass with summary or assign for manual review

Audit Logging → Capture rationale for the final compliance report

High Security :

Enterprise security posture
Strict security guardrails

Works seamlessly with your existing systems, no disruption, just faster, cleaner, audit-ready reviews

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.

Complementary to Veeva AI

PromoGuard™ proactively identifies potential compliance issues across multiple jurisdictions before formal review, while Veeva PromoMats manages the downstream MLR process.

PromoGuard™ adds country-relevant code intelligence and audit-ready rationale, integrating alongside existing platforms without replacement or lock-in.

Compliance PromoGuard™ is an AI-enabled pre-review tool. It is not a substitute for legal counsel, regulatory authority, or formal MLR processes. Strategic Growth AI does not provide legal advice. Customers are solely responsible for all final decisions

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.
Enterprise security with strict security guardrails

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 & AI Compliance for Life Sciences