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Turn Vision into Velocity with the Innovation CRO

Traditional CROs fragment device development with costly hand-offs and learning curves. Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.

All connected. All aligned. All accelerating your path to market—delivering breakthrough devices and diagnostics that improve patient lives sooner.

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Outcome-Driven Solutions for Medtech Challenges

Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.

Purpose-built solutions. Proven results. User & Patient-centered innovation.

 

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Purpose-Built for Breakthroughs

Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity.  Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.  

We are the Innovation CRO.

Legacy of excellence. Proven execution. Patient impact accelerated.

 

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Turn Our Insights Into Your Impact

From early feasibility to commercialization, progress depends on the right decisions at the right time. Get confident in your next step with blogs, case studies, and expert insights that cut through complexity and move development forward.

 

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Nicole Harada

Nicole Harada is Senior Associate, Regulatory Affairs. Nicole joined Veranex (legacy Experien Group) in 2017. At Veranex, Nicole drafts and reviews clients’ regulatory assessments and prepares documentation for U.S. regulatory submissions including Pre-Submissions, 510(k)s, De Novos, PMAs, IDEs, EFS IDEs, and Breakthrough Designations. Nicole supports team operations by managing project budgets, improving eSTAR and documentation processes, mentoring teammates, and creating new tools to streamline submission tracking and execution. Nicole also supports the business development team as a SME for regulatory on introduction calls and proposal/SOW drafting.