Translational Science Solutions

Strategic FDA Regulatory Consulting Services

 

trans·la·tion·al sci·ence [noun]:  

a multidisciplinary form of science with the goal of “translating” advances in basic science knowledge into clinical healthcare applications

ABOUT

kcbecker

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. 

Kathryn utilizes her in-depth knowledge of science, regulatory affairs, business planning, and product management to develop, coordinate, and execute business-minded regulatory strategies that help clients anticipate, meet and exceed FDA regulatory requirements.

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 investigational new drug (IND) applications and annual reports.

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.

Kathryn also serves as a member of the Executive Committee on the Board of Directors for SCBIO organization and as a co-chair of the SCBIO Annual Conference, also regularly serving as a speaker on panels at industry events. 

Previously, Kathryn was a Senior Consultant in the Translational and Regulatory Sciences at Bethesda, MD-based Precision for Medicine.  Prior to that, she served as a Research Associate, then Practice Manager for Pharmaceuticals and Biologics, for Washington, DC-based Becker & Associates Consulting, which is now part of NSF Health Sciences.  

Kathryn received a BS in Neuroscience from Davidson College and a Masters in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University.