EXPERIENCE
Navigating Innovation Through Regulation
Kathryn Becker founded Charleston-based Translational Science Solutions LLC with a clear mission: to guide groundbreaking life science and healthcare innovations through the FDA authorization process.
Leveraging her deep expertise in science, regulatory affairs, business strategy, and product management, Kathryn crafts forward-thinking regulatory pathways that meet and exceed FDA expectations. Her approach is as strategic as it is scientific—designed to anticipate challenges and deliver practical, business-focused solutions.
Specializing in the medical device sector, Kathryn helps clients navigate complex regulatory landscapes. Her services range from solving intricate regulatory puzzles and devising FDA strategies for cutting-edge products to preparing and overseeing critical FDA submissions and interactions, including Pre-Submission (Pre-Sub) meeting requests, Investigational Device Exemption (IDE) applications, 510(k) notifications, Premarket Approval (PMA) applications, Requests for Designation (RFD), and Breakthrough Device Designation (BDD) requests.
Kathryn Becker is a recognized leader in South Carolina’s life sciences community, shaping its future through business and nonprofit leadership. As chair of the SCBIO Foundation, she launched a program supporting students in life science internships and actively mentors innovation through grant reviews and industry speaking engagements.
She has held key leadership roles, including serving on SCBIO’s Executive Committee, co-chairing its annual conference, and leading the Southeast Medical Device Alliance and AdvanSE Conference. Her regulatory expertise spans industry and academia, with past roles at Precision for Medicine and Becker & Associates Consulting.
Kathryn holds a BS in Neuroscience from Davidson College and a Masters in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University.