ABOUT
Creative Solutions for Complex FDA Challenges
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, actively shaping its future through both her business and nonprofit involvement.
As the current chair of the SCBIO Foundation, she recently launched a pivotal program to provide financial support to students pursuing life science internships across the state. Her commitment to nurturing talent and innovation extends further as she serves as a grant peer reviewer, where she evaluates and champions groundbreaking projects, and as a regular speaker at industry events .
Kathryn's guidance has also been instrumental within SCBIO where she served on the Executive Committee of the Board of Directors and as co-chair of the SCBIO Annual Conference for several years, helping to shape the strategic direction of South Carolina’s life sciences industry. Her influence reaches beyond SCBIO, having chaired the Southeast Medical Device Alliance and led the AdvanSE Conference. She also served as the Chair of SCRA's Biotechnology Advisory Panel for several years and was a founding member of MUSC’s Medical Device Review Concept Board.
Before founding her consulting firm, Kathryn was a Senior Consultant in Translational and Regulatory Sciences at Precision for Medicine in Bethesda, MD. Prior to that, she held roles at Becker & Associates Consulting (now part of NSF Health Sciences) in Washington, DC, advancing from Research Associate to Practice Manager for Pharmaceuticals and Biologics.
Kathryn holds a BS in Neuroscience from Davidson College and a Master’s in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University.