MEDIcept Inc.
Lelia Adelina Paunescu has over 25 years of extensive experience in global clinical trials, specializing in various device trials, IVDs, and drug combinations. Currently serving as Head of Clinical Operations at Fractyl Health since April 2024, Lelia is adept in developing clinical strategies for regulatory submissions, including IDE, PMA, and 510(K). Lelia has held significant roles as a Strategic Advisor at MEDIcept Inc. and as Co-Founder and CEO of Kliniq, while previously leading clinical operations at multiple companies including HeartWare Inc. and TransMedics, Inc. Educationally, Lelia earned a PhD in Biophysics from the University of Illinois Urbana-Champaign and an MS in Physics from the University of Bucharest.
MEDIcept Inc.
1 followers
MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. We are an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, Clinical, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs. MEDIcept will help you navigate the complex FDA and international regulatory pathways, reduce business risk, and decrease time-to-market while maximizing your potential for success. Every client and every issue is unique. We customize our solutions to fit your needs. With a retention rate of over 90%, we can promise that you will benefit from working with us.