From Decision to Launch, Faster.
Turn regulatory readiness into speed, scale, and execution confidence.
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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When timelines slip, opportunity is lost. We help teams preserve momentum without increasing regulatory risk
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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​
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.
Confident & Compliant
Commercialization & Access
Commercialization support designed to align execution with regulatory and reimbursement expectations across Canada and the United States.
We help teams plan and execute go-to-market activities with awareness of pricing, coverage, and promotional standards, so commercial decisions are made with regulatory and downstream implications in mind.
This support is advisory and execution-focused, and does not replace formal regulatory, payer, or pricing authority.
Regulatory & Evidence
Execution support for Regulatory and Medical teams focused on consistency, traceability, and defensibility across submissions, updates, and commercial execution.
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Designed to support regulatory expectations in Canada and the U.S., including:
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Alignment between evidence, claims, and approved use
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Clear documentation and version control
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Audit-ready materials and review rationale
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Consistency across teams, assets, and lifecycle stages
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This capability supports regulatory workflows without replacing formal review, submission ownership, or decision authority.
Regulatory-Safe AI Workflows
AI-enabled workflows designed to support regulated execution with defined controls, transparency, and human oversight.
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Built to align with privacy, data governance, and promotional standards applicable across Canada and the U.S., including:
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Clear human-in-the-loop controls
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Traceable inputs, outputs, and decisions
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Support for promotional and execution standards
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Deployment within existing governance and review models
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These workflows are advisory by design, do not automate approval, and preserve regulatory and organizational authority at all times.
Why Teams Choose Us
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Combined Industry Experience: 40+ yrs, 100+ launches
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Regulatory-first: Built to survive IMC, MLR, Health Canada / FDA, and payer review
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AI with guardrails: Regulatory-safe automations that are auditable and integrated with your tech stack
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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.​​
Operational efficiency
Reduces manual administrative effort in compliance-heavy workflows
Planning and control
Supports consistent, defensible budgeting through
risk-aware scenario planning
​Audit-ready governance
Every action is traceable and reviewable for regulators, payers, and Medical, Legal, Regulatory (MLR)
Unlock Speed and Scale
Upstream risk review and planning support before MLR, rework, and escalation.
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Strategic Growth AI helps regulated life-sciences teams identify risk earlier, reduce avoidable friction, and make better decisions while there is still time to adjust, without replacing expert judgment or formal review.
🟦 OmniVynt™
Marketing Risk Review (Pre-MLR)
Primary users: Marketing, Brand, Commercial Excellence
Helps marketing and commercial teams pre-screen what they can say using jurisdiction-specific promotional expectations, before content is built, briefed to agencies, or submitted for medical, legal review.
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What it enables
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Flags promotional risk early
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Suggests compliant alternatives, not just rejections
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Reduces agency rework and late-stage escalation
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Improves first-pass submission quality
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Accelerates time to market​​
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âž¡ Explore OmniVynt
🟩 RegVynt™
Early Risk Detection and Review
Primary users
Compliance, Medical, Regulatory
Also supports: Commercial, Marketing, Market Access, and Operations by reducing rework, improving predictability, and accelerating time to market.
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Enable Compliance and Medical teams to operationalize consistent, defensible review across activities, venues, and programs, upstream of formal MLR and approval systems.
What it enables
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Detects repeat-pattern compliance risk early, before issues escalate
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Improves review consistency and audit defensibility across teams
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Reduces avoidable revisions and reviewer burden
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Preserves full human oversight at all times (no auto-approval)
Strategic Planning & Risk Review
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Applies the same risk intelligence used in compliance review to early commercial planning, initiative design, and investment proposals, before teams commit resources, budgets, or reputational capital.
Teams may use RegVynt™ to improve MLR readiness and first-pass quality, and/or extend its use upstream into planning as value is established.
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âž¡ Explore RegVynt
How They Work Together
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OmniVynt helps teams decide what’s safe to build.
RegVynt helps teams govern what gets approved.
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Both operate upstream of formal review systems, supporting faster, cleaner execution without replacing expert judgment.
🟧 DeviceVynt™
MedTech & Medical Device Risk Review
Helps medical device and medtech teams assess whether product claims, intended use descriptions, and field messaging remain aligned with regulatory classification and approvals, before materials are finalized or used in the field.
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Primary users: Regulatory Affairs, Product Management, Commercial Operations, Sales Enablement
Also supports: Marketing and Business Development by reducing rework, preventing unintended claim expansion, and improving submission and review predictability.
What it enables
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Flags claim and intended-use drift early
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Identifies implied clinical or diagnostic overreach
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Aligns sales and marketing language with regulatory classification
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Highlights jurisdiction-specific risk (FDA, EU MDR, Health Canada)
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Reduces late-stage RA intervention and field corrections
Result: Cleaner materials, fewer field compliance issues, reduced regulatory exposure, and faster, more confident execution, without touching patient data.
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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.
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Ingests and cleanses data from SAP, Concur, and CRO portals into a unified source of truth.
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Uses "Identity Resolution" to map disparate records to unique HCP identifiers (NPI/License).
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Classifies transactions (e.g., consulting vs. meals) and offers a pre-disclosure portal for HCP dispute resolution.
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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.
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Intelligent Intake agent OCRs incoming fax enrollment forms and instantly flags missing data.
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Connects to payer portals to automate Benefit Verification and Prior Authorization using clinical evidence from the EHR.
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Generates customized appeal letters citing clinical guidelines if a PA is denied.
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Operational Automation Modules
Automate. De-Risk. Grow.
Our Services
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Reduce administrative burden by automating manual, repetitive workflows across clinics, PSPs, and commercial operations.
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Support launch and planning decisions by applying structured, risk-aware forecasting and scenario analysis to key commercialization assumptions.
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Frame complex trade-offs clearly using probabilistic planning models (e.g., Monte Carlo–based sensitivity analysis, rNPV-style valuation logic, IRR-informed scenarios) to support governance review and documented decision-making.
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Built to Fit Your World
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System Integration
Designed to integrate with existing enterprise systems (e.g., Veeva, Snowflake, EMR, CRM), enabling orchestration across workflows rather than introducing another disconnected tool.
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Compliance by Design
Workflows are built with industry-standard privacy, compliance, and data governance requirements in mind (e.g., IMC-aligned processes, HIPAA/GDPR considerations, data residency controls), with audit-ready logging and traceability.
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Training & Support
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Structured onboarding, documentation, and ongoing support to ensure teams adopt workflows correctly and consistently.​
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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