Translational Science Solutions LLC

Kathryn Cole Becker established Charleston, SC-based Translational Science Solutions LLC to facilitate the commercialization of innovative life science and healthcare products at all stages of development. Working primarily in the medical device space, services include the analysis of complex regulatory challenges, development of regulatory strategies for pioneering products, and preparation and stewardship of related submissions and interactions with FDA on behalf of clients, including Pre-Submission (Pre-Sub) meeting requests, investigational device exemption (IDE) applications, 510(k) premarket notification submissions, premarket approval (PMA) applications, requests for designation (RFD), and other regulatory communications. Additional capabilities include FDA quality systems and inspection support, due diligence reports and analysis for healthcare investments and acquisitions, project management and litigation support, critical review of scientific data and regulatory literature, preparation of comments to the docket for new proposed rules or guidance documents on behalf of clients, and authorship of reports on healthcare-related topics. Clients range from entrepreneurs in South Carolina developing their first product to multi-national, publicly-traded companies with diverse product portfolios.