Strategic regulatory leadership to define clear pathways, reduce risk, and accelerate approvals across US and global markets.
A strong regulatory strategy begins early and evolves with your program. Pathfinder helps you define the most efficient path to approval while minimizing costly late-stage changes.
Before committing to a pathway, evaluate the regulatory landscape to define a clear starting point.
A comprehensive, forward-looking regulatory plan tailored to your product and markets.
Strategic and hands-on support across the full submission lifecycle.
Early and effective engagement with regulators — including FDA pre-submissions.
Avoid costly missteps and delays by embedding regulatory thinking early.
Too often, regulatory strategy is brought in late — after key product decisions are already made. At that stage, changing direction becomes costly and time-consuming. Pathfinder works with teams early and throughout development, helping guide each stage.
Defining indications, intended use, and differentiation.
Aligning testing, validation, and clinical strategy.
Ensuring the chosen pathway is efficient and viable.
Preparing documentation and managing agency interactions.
This approach ensures regulatory considerations are built into the program — not layered on at the end.
Accelerated EU MDR timelines for high-risk devices through early alignment and parallel strategy execution.
Preparing for early feasibility or pivotal studies.
Companies navigating high-stakes submission pathways.
Teams expanding indications or entering new global markets.
Organizations needing senior regulatory leadership on a flexible basis.
Regulatory strategy is embedded from the beginning — reducing risk and avoiding costly pivots later.
Work directly with an experienced regulatory leader with deep Class III device experience.
Translate evolving regulatory expectations into clear, actionable plans.
Focus on the most streamlined path — balancing time, cost, and regulatory success.
Founder & Principal Consultant
Pathfinder Regulatory Consulting was founded by Elizabeth George, RAC, a regulatory affairs leader specializing in global regulatory strategy for high-risk medical devices.
She previously served as a Principal Regulatory Affairs Specialist at Medtronic, where she led regulatory strategy for PMA and EU MDR programs and supported accelerated approvals for complex cardiovascular technologies.
Elizabeth brings a practical, results-driven approach — helping teams define clear regulatory pathways, align early with health authorities, and navigate complex development programs with confidence.
Whether you're at the concept stage or preparing for submission, Pathfinder Regulatory Consulting helps you identify the right regulatory strategy early — so you can move forward efficiently and avoid costly surprises.
Or reach out directly at elizabethgeorge@pathfinderregulatoryconsulting.com