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Accelerate Your Diagnostic Journey
Expert guidance in assay development, quality systems, regulatory strategy, and executive leadership
NextPhaseDx partners with start-ups, research teams, and established developers to advance diagnostics from early assay design through validation, regulatory clearance, and commercialization.
We provide the technical, regulatory, and strategic leadership needed to align innovation with compliance and accelerate your path to market.
Our Expertise
We guide start-ups and academic teams through the critical phases of diagnostic development. Our support spans early assay design, quality systems, regulatory submission, and executive strategy.
Assay Development & Validation
We provide consultative guidance to help academic teams and start-ups transition from early biomarker discovery into structured diagnostic development. We align your assay concepts with FDA design control requirements, ensuring studies are documented, risks are managed, and development progresses on a clear path toward analytical & validation, and regulatory clearance.
Quality Systems & QMSR Compliance
We help young companies build right-sized quality systems that comply with FDA’s new QMSR, ISO 13485, and IVDR. Through consultative planning, we tailor frameworks that are scalable, audit-ready, and aligned with your stage of growth — avoiding overbuilt systems while preparing for global markets.
Regulatory Strategy & Submissions
NextPhaseDx partners with your team to map the regulatory pathway from discovery through clearance. We provide strategic guidance on Q-Submissions, PMA, 510(k), De Novo and EUA strategies, as well as regulatory integration for BARDA, NIH, and DoD funding programs—ensuring your submission package and milestones align with both FDA and agency expectations.
Fractional Leadership & Executive Guidance
NextPhaseDx provides executive-level leadership without the overhead of a full-time hire. Acting as a fractional CSO, COO, or CEO, we guide strategy, investor engagement, partnerships, and technical oversight — helping early-stage diagnostics teams accelerate progress with experienced leadership.
Who We Are
Scientific Expertise. Strategic Guidance. Proven Results.
Founded by Dr. Richard J. Kowalski, NextPhaseDx partners with academic innovators and emerging biotech teams to translate diagnostic discoveries into validated, regulatory-ready products.
With more than 30 years of experience in in-vitro diagnostics (IVD), FDA design controls, and federally funded SBIR/STTR programs, we bridge innovation and compliance—helping each program move efficiently from concept through clinical validation and market readiness.
Dr. Kowalski earned his Ph.D. in Molecular Biology from Vanderbilt University, where his NIH/NCI-funded research on microtubule dynamics laid the foundation for a career translating complex biological discoveries into practical diagnostic applications.
As a small business prime, NextPhaseDx leads and manages SBIR/STTR collaborations with universities and research organizations, providing the scientific, regulatory, and operational leadership needed to deliver results.
What People Say
David Winer, Director & Program Manager – Medical Devices R&D
“Rich’s expertise in assay development and ability to communicate complex biology clearly make him an invaluable collaborator on any diagnostics program.”
Teri Toth, Quality Systems Professional
“Rich’s deep understanding of Quality Systems and FDA requirements ensures every project meets the highest compliance standards.”
Matt Snyder, COO, ASELL, LLC
“Rich’s scientific depth and regulatory insight guide teams through design controls and FDA strategy with clarity and precision.”
Martin Rosendale, CEO Advisor & Biotechnology Executive
“Rich blends technical depth with strategic leadership—aligning diagnostics innovation with business goals and customer needs.”