top of page
_edited.jpg){kind=logo}
Our Mission
At NextPhaseDx, our mission is to bridge the gap between academic discovery and regulated diagnostic development. We support innovators navigating the transition from early feasibility into FDA-aligned development by applying disciplined scientific judgment, regulatory insight, and practical development structure.
Early-stage diagnostic programs often face the challenge of advancing promising science while meeting evolving regulatory and quality expectations. Our role is to help teams introduce the appropriate structure, documentation, and decision-making frameworks needed to support compliant, submission-ready development without compromising scientific intent.
By integrating scientific expertise with quality and regulatory discipline, we help ensure that early investment, whether academic, institutional, or externally funded, leads to sustained progress toward validation, regulatory engagement, and long-term impact.
How We Work
Diagnostic development programs consistently face the challenge of transitioning strong science into structured, regulated development. NextPhaseDx partners with teams to connect early research success with the regulatory, quality, and design frameworks required for diagnostic development.
We guide your team through:
-
Structured assay development
Guiding the transition from exploratory biomarker research to development activities aligned with FDA design control principles. -
Quality system implementation
Introducing right-sized QMSR-aligned practices that integrate documentation, traceability, and risk management into development workflows. -
Regulatory strategy and validation planning
Aligning regulatory pathway decisions, FDA engagement, and validation planning with program maturity and intended use. -
Fractional executive guidance
Providing experienced diagnostic leadership to align scientific, regulatory, and organizational priorities across development stages.
Each collaboration is structured to support disciplined progression and sustained regulatory readiness as programs advance.
Our Approach
At NextPhaseDx, we believe diagnostic innovation progresses most effectively when scientific rigor and regulatory structure advance together. Our approach is grounded in collaboration, adaptability, and regulatory foresight, helping early-stage teams build with intention and avoid downstream rework.
NextPhaseDx frequently partners with universities, research institutions, and early-stage companies to support funded and internally sponsored diagnostic development programs. We provide scientific, regulatory, and operational leadership appropriate to early development while maintaining flexibility as programs evolve.
Rather than applying a one-size-fits-all process, we tailor each engagement to program maturity, development goals, and internal capabilities. We focus on strengthening what is already working while integrating the quality and regulatory practices required to meet FDA expectations at the appropriate pace.
Our Story
Founded by Dr. Richard Kowalski, NextPhaseDx was established to support innovators navigating the early stages of diagnostic development, particularly as programs transition from discovery into regulated development.
With over 30 years of experience in in vitro diagnostics, FDA design controls, and federally supported development programs, Dr. Kowalski recognized a recurring challenge. Early-stage teams often generate compelling data and secure initial support, yet lack the development structure, documentation, and regulatory strategy needed to progress toward validation and FDA engagement.
NextPhaseDx was created to address this gap by providing experienced scientific, quality, and regulatory leadership that enables disciplined progression from concept to submission-ready diagnostics.
Dr. Kowalski holds a Ph.D. in Molecular Biology from Vanderbilt University.
bottom of page