Our Advisory Practices

Innovation succeeds when regulatory clarity, clinical discipline, and AI oversight align. We guide organizations through submissions, trial governance, and AI adoption — ensuring that solutions withstand regulator scrutiny, accelerate timelines, and build investor and board confidence.

Focus Areas

• Global submissions: FDA (510(k), De Novo, PMA), U.S. and international authorities (MHRA, PMDA, Health Canada).
• Clinical trial governance: vendor oversight, adaptive trial designs, and ICH GCP compliance.
• AI & SaMD lifecycle oversight: classification, PCCPs, and alignment with FDA GMLP, EU AI Act, ISO/IEC 42001.
• Data protection & compliance: GDPR, HIPAA, and evolving clinical trial regulation standards.
   

Impact

• Shortened FDA review cycles for AI-enabled diagnostics by six months.
• Achieved first-pass certifications across portfolios under new global frameworks.
• Strengthened board and investor confidence in AI maturity and regulatory readiness.
   

Who We Support

• Startups seeking first approvals or pivotal trial execution.
• Growth firms preparing for complex submissions and AI adoption.
• Investors requiring clarity on regulatory and trial risks before funding decisions.

AI is transforming diagnostics, clinical trials, and digital health — but without governance, it creates risk. We help leaders scale AI responsibly, embedding explainability, lifecycle control, and inspection-ready data practices so innovation earns trust and withstands scrutiny.

Focus Areas

• Responsible AI adoption in diagnostics, clinical development, and digital health platforms.
• Governance frameworks for transparency, explainability, and audit-readiness.
• GxP-compliant data ecosystems ensuring interoperability, validation, and inspection readiness.
• Proprietary frameworks (SIGFOC™, PTRS™, RRQ™) that simplify oversight and accelerate executive decision-making.
   

Impact

• Enabled a global MedTech operator to implement enterprise AI governance aligned with FDA GMLP and ISO/IEC 42001, reducing audit exposure.
• Delivered AI risk assessments that shaped investment strategy for a $100M+ digital health acquisition.
• Helped scale-ups move from “AI concept” to regulator-trusted, investor-ready solutions.
   

Who We Support

• Digital health innovators building SaMD and remote monitoring platforms.
• Established firms modernizing data and AI governance across enterprises.
• Investors evaluating AI-driven business models in due diligence.

Approval is only the beginning; adoption drives impact. We integrate regulatory, clinical, and commercial strategy so that products not only gain approval but also achieve payer adoption, reimbursement, and sustained market leadership.

Focus Areas

• Market access and reimbursement strategies for diagnostics, MedTech, and digital health.
• HTA and payer readiness supported by strong clinical and economic evidence.
• Lifecycle and post-market strategies: surveillance, pharmacovigilance, and real-world data.
• Go-to-market planning with KOL engagement, launch readiness, and scale-up strategies.
   

Impact

• Secured payer adoption for AI-enabled diagnostics across U.S. and European markets.
• Protected uninterrupted market access for a portfolio facing new compliance thresholds.
• Built commercialization strategies that sustained long-term enterprise value.
   

Who We Support

• Startups seeking payer adoption and reimbursement validation.
• Growth firms preparing launches in multiple markets.
• Investors evaluating market access risk during diligence.

Compliance should accelerate, not delay, innovation. We integrate design controls, risk management, and quality systems into lean roadmaps that protect approvals, secure inspections, and enable sustainable scale.

Focus Areas

• Design controls aligned with ISO 13485, 21 CFR 820, and global standards.
• Quality system buildouts and remediation across 20+ markets.
• Risk management frameworks (ISO 14971, ICH Q9) embedded into daily operations.
• Vendor, CRO, and third-party oversight ensuring execution continuity.
   

Impact

• Positioned diagnostics and digital health platforms for successful global launches.
• Reduced audit and inspection exposure through enterprise QMS remediation.
• Delivered integrated risk management strategies that supported scale and investor confidence.
   

Who We Support

• Innovators developing AI-enabled diagnostics and devices.
• Growth firms under remediation or inspection pressure.
• Global operators scaling complex quality platforms.
   

Every milestone — fundraising, cross-border expansion, or organizational transformation — depends on readiness. We prepare leaders and boards to navigate these moments with clarity, discipline, and confidence.

Focus Areas

• Investor and capital readiness: aligning AI maturity, regulatory strength, and diligence expectations.
• Strategic growth: cross-border expansion integrated with reimbursement and regulatory pathways.
• Leadership & organizational coaching for CEOs, founders, and boards navigating scale or pivots.
• Transaction support: independent diligence in high-stakes contexts, including acquisitions exceeding $100M.
   

Impact

• Supported successful fundraising strategies for digital health startups.
• Guided boards through complex organizational transformations.
• Provided diligence and insight that shaped high-value M&A outcomes.
   

Who We Support

• Early-stage firms preparing for capital raises.
• Established players managing leadership transitions and global growth.
• Investors requiring trusted diligence for high-value transactions.