De-risk Regulatory
 Launch Smarter

Strategic Growth AI's regulatory execution engine transforming complexity into competitive advantage

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1. Clear Value & ROI: Quantified Outcomes, Not Promises

We deliver measurable impact:

• 30–40% faster submissions via predictive pathway modeling

• $8.2M avg. cost avoidance by eliminating rework

• 50% shorter sales cycles through early payer alignment

• 2.3x faster KOL activation with AI-driven engagement

Example: A rare disease biotech cut FDA review time by 5 months — unlocking $210M in earlier revenue.

 

2. Strategic Market Penetration: Phased Entry, Global Reach

We build concise, payer-first strategies for:

• U.S.: FDA pathways + CMS coverage + Breakthrough Device support

• Canada: Health Canada + CADTH/INESSS + provincial formularies

• Europe: CE Marking (MDR) + EMA advice + HTA alignment (NICE, HAS)

Aligned from Day 1 — so approval leads directly to adoption.

 

3. Evidence-Backed Differentiation: HEOR, RWE & Clinical Validation

Payers demand proof. We deliver:

• Health Economics (HEOR) models showing cost savings

• Real-World Evidence (RWE) frameworks for post-market success

• GMLP-aligned validation for AI/ML products

• Regulatory-grade dossiers that double as payer submissions

Result: One client secured 3 provincial reimbursements in 90 days post-approval.

 

4. KOL Engagement: Activate Champions, Not Just Advisors

We identify and empower high-impact KOLs with:

• AI-powered influence mapping

• Tailored engagement plans (advisory boards, publications)

• Peer-to-peer education campaigns

Outcome: 62% increase in referrals within 6 months.

 

5. Hospital & CHE Engagement: AI-Powered Stakeholder Mapping

We pinpoint decision-makers before launch:

• Clinical champions

• Procurement leads

• Operational gatekeepers

Impact: 80% hospital engagement pre-launch, cutting sales cycle in half.​

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