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.
Company Details
- Employees
- 1
- Founded
- -
- Address
- 25 Savage St, Charleston,south Carolina 29401,united States
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- tss-consult.com
- Keywords
- FDA, Regulatory Strategy, Medical Device, FDA Submissions, FDA Strategy, 510(k), Pre-Sub Meeting, PMA, IDE.
- HQ
- Charleston, South Carolina
Translational Science Solutions Llc Questions
Translational Science Solutions Llc's website is tss-consult.com
Translational Science Solutions Llc's LinkedIn profile is https://www.linkedin.com/company/tss-consult-llc
Translational Science Solutions Llc has
1 employees.
View email and phone details for 1
employees at Translational Science Solutions Llc.
Translational Science Solutions Llc's industry is
Business Consulting and Services
Translational Science Solutions Llc's top competitors are
Rook Quality Systems,
Nsf,
Applovin,
Translational Biotech Solutions, Llc.
Translational Science Solutions Llc's categories are Business Consulting and Services
Translational Science Solutions Llc's founding year is 2014
