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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

    • 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

    • 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

    • IDE Preparation

    • Protocol Development

    • Biostatistical Support

    • 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.

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