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. Elizabeth brings more than a decade of experience navigating complex regulatory pathways across the product lifecycle, helping organizations accelerate development programs, reduce regulatory risk, and achieve successful market access.
Prior to founding Pathfinder, Elizabeth served as a Principal Regulatory Affairs Specialist at Medtronic, where she led regulatory strategy for PMA and EU MDR programs supporting Class III implantable cardiovascular devices. Her experience includes driving accelerated approval timelines, developing innovative regulatory strategies, and partnering with cross-functional teams to align clinical, technical, and commercial objectives.
Elizabeth is Regulatory Affairs Certified (RAC) across drugs, devices, and biologics and holds a Master of Science in Food Safety and Compliance from Cornell University and a Bachelor of Technology in Biotechnology from Vellore Institute of Technology. She combines deep technical expertise with a practical, business-focused approach, helping teams define clear regulatory pathways, engage effectively 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