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Expert Guidance for FDA-Aligned In Vitro Diagnostic (IVD) Development
NextPhaseDx partners with academic and early-stage industry teams to guide diagnostic programs from early biomarker discovery through analytically and regulatory-aligned development, validation, and FDA submission.
Our approach emphasizes disciplined development under design controls, practical quality system implementation, and regulatory strategies aligned with established FDA review expectations.
Our Expertise
Hands-on diagnostic development and scientific leadership across the translational pipeline
NextPhaseDx partners with academic and early-stage industry teams to guide diagnostic programs through key transitions from discovery into FDA-aligned development and validation. Our work emphasizes disciplined development under design controls, regulatory strategy, and experienced leadership applied at critical decision points.
Assay Development & Validation
Translating biomarker discoveries into structured diagnostic development
NextPhaseDx supports academic and early-stage industry teams as they transition promising biomarker findings into assay development programs aligned with FDA design control expectations. Our role is to help bring structure, regulatory awareness, and development discipline to assay work while preserving scientific intent and flexibility.
Our involvement in assay development commonly includes:
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Guidance on assay design, optimization, and platform selection
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Planning for analytical validation in the context of intended use
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Integration of risk management and design inputs into development activities
This support is particularly valuable when:
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Biomarker feasibility has been demonstrated, but development lacks regulatory structure
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Assay activities are progressing without clear alignment to validation expectations
Quality Systems & QMSR Compliance
Implementing FDA-aligned quality practices appropriate to program maturity
NextPhaseDx works with early-stage diagnostics teams to establish quality system practices that support development under FDA design controls while remaining appropriate to program maturity. Our focus is on helping teams implement right-sized, usable quality systems that enable progress today and scale as regulatory expectations increase.
Our work in this area often includes:
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Assessment of quality system readiness relative to FDA QMSR expectations
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Implementation of design control processes integrated with ongoing development
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Guidance on document control and risk management practices
This support is particularly valuable when:
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Development activities are advancing ahead of formal quality system structure
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Teams are preparing for external funding milestones or early regulatory engagement
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Organizations need to balance development velocity with compliance readiness
Regulatory Strategy & Submissions
Defining clear regulatory pathways for diagnostic development
NextPhaseDx works with academic and early-stage industry teams to define appropriate FDA regulatory pathways and align development activities accordingly. Our focus is on helping teams make early, well-informed regulatory decisions that reduce downstream uncertainty and support efficient progression toward submission and review.
Our work in this area often includes:
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Assessment of regulatory classification, pathway, and intended use
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Alignment of development and validation activities with regulatory expectations
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Preparation for FDA interactions, including pre-submission planning
This support is particularly valuable when:
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Regulatory pathways or classification remain unclear
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Development activities are advancing without regulatory alignment
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Teams are preparing for initial FDA interactions or future submission planning
Fractional Leadership & Executive Guidance
Experienced diagnostic leadership embedded within development programs
NextPhaseDx provides fractional scientific and technical leadership to early-stage diagnostics teams that require senior-level guidance without adding permanent headcount. This model supports informed decision-making, cross-functional alignment, and continuity across technical, regulatory, and funding-related inflection points.
Our work in this area often includes:
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Strategic guidance on diagnostic development and regulatory planning
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Coordination across scientific, regulatory, and external partner teams
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Technical representation in discussions with funders, boards, and agencies
This support is particularly valuable when:
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Programs are advancing without dedicated senior diagnostics leadership
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Teams are navigating complex technical or regulatory decision points
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Organizations require experienced leadership during periods of transition
Who We Are
Scientific expertise. Regulatory judgment. Experienced leadership.
NextPhaseDx was founded by Dr. Richard J. Kowalski to support academic and early-stage industry teams navigating the transition from biomarker discovery into FDA-aligned in vitro diagnostic development.
With more than 30 years of experience in in vitro diagnostics, FDA design controls, and federally supported development programs, Dr. Kowalski brings senior-level scientific, quality, and regulatory judgment to early-stage IVD programs at critical points in their development.
His background includes NIH- and NCI-funded research, translational assay development, and leadership of regulated diagnostics programs, with a focus on introducing development discipline, regulatory alignment, and documentation appropriate to program maturity.
NextPhaseDx operates as a focused, hands-on partner, providing experienced guidance to help teams progress from discovery through validation and regulatory engagement without compromising scientific intent.
Professional Perspectives
Testimonials reflect professional collaborations with Dr. Richard J. Kowalski and inform the experience brought to NextPhaseDx engagements.
David Winer
Director and Program Manager – Medical Devices R&D
“Rich’s expertise in assay development and ability to communicate complex biology clearly make him a valuable collaborator on complex diagnostics programs.”
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 and Biotechnology Executive
“Rich blends technical depth with strategic leadership—aligning diagnostic innovation with organizational goals and stakeholder needs.”