Why Clearpath Healthtech
A different model for regulatory, clinical and commercial advisory in health and medical technology.
We combine deep regulatory, clinical and commercial expertise with a delivery model designed for speed, flexibility and commercial reality.
Our team has operated across regulators, industry and advisory, giving us a complete view of the challenges facing companies at every stage.
A gap in the market
The advisory market presents a clear challenge for health and medical technology companies.
Firms with the deepest expertise often come with cost structures and timelines that do not work for growth-stage businesses. At the other end of the market, more affordable options can lack the breadth of experience required to identify the full picture.
This creates risk. Critical regulatory, clinical and commercial dependencies are often missed until late in development, during submission or in transaction processes.
Clearpath Healthtech bridges that gap.
A different approach
Depth of expertise
Life science PMO
R&D engineer
FDA & EU MDR
Commercial BD
Notified Body decision-maker
KPMG deal advisory
Health economist
Industry veteran
We combine the insight typically found in large consultancies with a delivery model designed for speed, flexibility and commercial focus.
Our team brings experience from Notified Bodies, global MedTech organisations and deal advisory environments. This allows us to identify risks, dependencies and opportunities that siloed specialists often miss.
We work across regulatory, clinical and commercial pathways to provide joined-up advice that reflects the full product and business lifecycle.
Insight
Big consultancy-level thinking
We bring senior experience from Notified Bodies, big 4 consultancy deal advisory and global health and medical technology organisations. This allows us to assess regulatory and clinical strategy in the context of commercial and investment decisions.
Delivery
Senior-led, efficient execution
Every engagement is led by experienced professionals. We focus on delivering clear, practical outputs without unnecessary layers or delay, allowing teams to move forward quickly with confidence.
Economics
Designed to work at every stage
Our model combines the rigour of large consultancies with a structure that works for scaling businesses, ensuring access to high-quality expertise without excessive cost.
Selected credentials
Examples of work delivered across regulatory, clinical and commercial programmes.
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Regulatory due diligence - acquisition
Led regulatory due diligence assessing product risk, approval status and remediation requirements, contributing to a €1.2 billion transaction.
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Global pharmaceutical - engagement
Secured and delivered a multi-year regulatory compliance programme supporting product approvals and ongoing market access.
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First-in-human gene therapy trial
Achieved clinical trial authorisation for an AAV-based gene therapy targeting Huntington’s Disease, supporting early-stage clinical development.
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MDR remediation - Global MedTech company
Delivered clinical evaluation and MDR remediation across Class IIa, IIb and III devices, supporting continued EU market access.
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AI skin cancer diagnostic - PRRC
Acting Person Responsible for Regulatory Compliance across FDA, UKCA and CE pathways for an AI-enabled diagnostic platform.
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Oncology diagnostics - national scale deployment
Supported regulatory and clinical strategy for AI-powered oncology diagnostics across the UK and Europe.
“Regulatory maturity is a value lever, not an overhead. Regulatory is a financial asset.”
Experience you can rely on
50+
Years of combined life sciences experience
100+
Life sciences and regulatory projects delivered
20+
Global markets supported
Multi-sector
Regulatory, clinical and commercial expertise
Speak to the team
Clear, practical guidance across regulatory, clinical and commercial decisions.