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Our Mission
Accelerate Your Diagnostic Journey
At NextPhaseDx, our mission is to bridge the gap between academic discovery and regulated diagnostic development—helping SBIR and STTR-funded innovators move efficiently from early feasibility to validated, submission-ready products.
We understand that early-stage teams face the dual challenge of maintaining scientific rigor while meeting regulatory and funding expectations. Our role is to provide the structure, strategy, and systems that transform promising assays into compliant, development-stage diagnostics.
By integrating scientific insight with quality and regulatory expertise, we enable innovators to convert grant-funded research into sustainable progress, advancing diagnostics that are ready for the next phase of validation and commercialization.
How We Work
Every funded diagnostic project faces the same challenge: turning strong science into structured development. NextPhaseDx partners with SBIR and STTR teams to connect early research success with the regulatory, quality, and design frameworks required for product realization.
We guide your team through:
Structured assay development -
translating early biomarker discoveries into regulated product designs built under FDA Design Control principles, ensuring clear documentation, risk management, and verification planning.
Quality system implementation -
guiding the design and deployment of QMSR-compliant processes that embed documentation, traceability, and continuous improvement from the start.
Regulatory strategy and validation planning -
integrating Q-Sub engagement, analytical and clinical study design, and data integrity practices to ensure submission-ready evidence.
Fractional executive guidance -
providing senior-level leadership to align technical, regulatory, and business objectives from discovery through market readiness.
Each collaboration is structured to accelerate development and build lasting readiness for the next phase of funding or FDA submission.
Our Approach
At NextPhaseDx, we believe that innovation moves fastest when science and structure advance together. Our approach is grounded in collaboration, adaptability, and regulatory foresight—helping early-stage diagnostic teams build with intention, not rework.
As a small business prime under SBIR and STTR programs, we partner with universities, research institutions, and biotech teams to lead funded projects from feasibility through validation. We manage the scientific, regulatory, and operational components needed for compliance while maintaining the flexibility required in early development.
Rather than applying a one-size-fits-all process, we tailor each engagement to a team’s stage of development, funding goals, and internal capabilities. We align with your existing resources, strengthen what’s already working, and integrate what’s needed to meet QMSR and FDA expectations at the right pace.
Our philosophy is simple: the earlier a team integrates quality and regulatory structure, the smoother the transition from SBIR/STTR feasibility to clinical validation. By embedding compliance early and proportionally, we help maintain momentum—and keep your path to FDA submission clear.
Our Story
Founded by Dr. Richard Kowalski, NextPhaseDx was established to support innovators navigating the early stages of diagnostic development — particularly those advancing through SBIR and STTR-funded programs.
With over 30 years of experience in in-vitro diagnostics (IVD), FDA design controls, and federally funded product development, Dr. Kowalski recognized a common challenge: while early-stage projects often generate promising data and secure funding, many struggle to implement the structured design, documentation, and regulatory strategy needed to reach clinical validation and market readiness.
NextPhaseDx bridges that gap.
We provide the scientific, quality, and regulatory framework that enables SBIR/STTR teams to progress efficiently—from concept to prototype and from prototype to submission-ready diagnostics.
Our mission is to accelerate diagnostic innovation by ensuring that early funding leads to measurable impact through regulatory compliance, quality execution, and sustainable progress.
Dr. Kowalski holds a Ph.D. in Molecular Biology from Vanderbilt University.