Practical solutions for complex FDA challenges.
Bridging science, business, and regulatory affairs to drive smart FDA strategy, seamless submissions, and accelerated market entry
ABout US
We balance business objectives and the complexities of FDA regulations to ensure efficient and successful market entry for medical device and digital health companies, including healthcare startups, established medical device manufacturers, and academic innovators.
We understand that every product and company is unique, which is why we think creatively about the challenges you face, and offer tailored solutions in regulatory strategy development, FDA submission management, and post-market support—all aimed at turning innovative ideas into market-ready products.
Our Services
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Software as a Medical Device & Digital Health
Wearables & Remote Monitoring
Next-Generation Medical Imaging & AI
Antimicrobial & Infection Control Claims
Neonatology & Perinatal Health
Women’s Health & Urology
Pulmonary & Respiratory Health
Metabolic & Endocrine Health
Neurology & Mental Health
Rehabilitation & Assistive Devices
Orthopedic & Implantable Devices
Cardiovascular & Imaging
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510(k) Premarket Notifications
Pre-Submission Meetings
Breakthrough Device Designations
Investigational Device Exemptions
De Novo Reclassification Petitions
Enforcement Discretion Confirmation
513(g) Requests
Official FDA Correspondent
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IDE Preparation
Protocol Development
Biostatistical Support
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Assessment of Post-market Changes
Comments to Proposed Rules
Market Analysis
Ongoing Regulatory Support
Vendor Identification & Management
Fractional Head of Regulatory Affairs
Peer Reviewer
Industry Speaker
Our Experience
Kathryn Becker founded Translational Science Solutions in 2014 to help life science and healthcare innovators successfully navigate the FDA authorization process. With deep expertise in science, regulatory affairs, business strategy, and product management, she develops forward-thinking regulatory strategies that anticipate challenges and drive business-focused solutions. A regulatory speaker and recognized leader in South Carolina’s life sciences community, Kathryn actively shapes its future through both her consulting work and nonprofit leadership.
As current chair of the board of the SCbio Foundation, she launched a statewide program supporting students in life science internships. Her commitment to innovation extends to grant peer review, championing groundbreaking projects, and speaking at industry events. Kathryn has played a key role in SCbio’s strategic direction, serving on the Executive Committee, co-chairing the SCbio Annual Conference, and leading initiatives across the Southeast Medical Device Alliance, AdvanSE Conference, and SCRA's Biotechnology Advisory Panel.
Kathryn has over 15 years of experience helping clients tackle complex regulatory challenges in a multitude of medical specialties, having previously worked for Washington, DC-based Becker & Associates Consulting (now NSF International) and Bethesda, MD-based Precision for Medicine. She holds a BS in Neuroscience from Davidson College and a Masters in Biotechnology Enterprise and Entrepreneurship from The Johns Hopkins University.