Launch your diagnostic lab on time.
Launch your diagnostic lab on time.
Launch your diagnostic lab on time.
Launch your diagnostic lab on time.
We help early-stage diagnostics companies and specialty laboratories prepare for CLIA certification, achieve CAP inspection readiness, and build compliant operational systems that scale with growth.
By focusing on outcomes instead of paperwork, we help teams avoid
costly inspection delays and strengthen their compliance
foundations before inspection day.
We believe that the key to success is a collaborative approach that puts your needs first. Our team works closely with you every step of the way to ensure that our solutions are aligned with your goals and objectives.
We offer straightforward solutions that will launch your lab to the next level.
Let's work together to achieve your goals.
Built by leaders with hands-on diagnostics and laboratory experience.

Founders preparing to launch CLIA- and CAP-compliant laboratories can benefit from clear regulatory assistance, operational readiness, and inspection confidence—without costly delays or rework. Leverage strategic insights to implement CAP/CLIA-ready systems quickly, hit launch milestones with fewer delays, and avoid common deficiencies on inspection days.

Established or growing laboratories looking to expand test menus, platforms, or volume can do so while maintaining inspection readiness, quality systems, and regulatory compliance at scale. Expand test menus with confidence, scale laboratory operations with compliant systems, and maintain quality to minimize backlogs.

Leadership teams in need of senior-level regulatory and operational expertise can reduce risk, meet milestones, and protect enterprise value without hiring a full-time compliance executive. Access fractional expertise to gain strategic insights and reduce regulatory risk, ultimately protecting valuations.
Gain strategic insights into laboratory operations with our expert guidance on CLIA & CAP compliance, operational readiness, and regulatory assistance tailored for early-stage diagnostics companies.
Our team specializes in enhancing laboratory operations by providing regulatory assistance and delivering strategic insights that help streamline processes and ensure compliance.
A structured gap assessment aligned with CAP/CLIA requirements will provide valuable regulatory assistance for laboratory operations. This will lead to a prioritized action plan and a clear launch timeline, offering strategic insights for effective implementation.
Establish comprehensive documentation for laboratory operations, including validation frameworks and workflows. Ensure personnel competency to enhance regulatory assistance and maintain inspection readiness while providing strategic insights.
Assess critical gaps in your laboratory operations against CLIA/CAP standards. Prioritize what matters for inspection success with strategic insights. Implement sustainable documentation and processes to streamline regulatory assistance. Prepare your team to effectively walk inspectors through the story of your operations. Reduce regulatory timelines by 30–50% while staying fully compliant. For remediation assessments, we provide deficiency response support, and our remediation plan offers targeted fixes to quickly close gaps.
Ongoing oversight for quality systems in laboratory operations. New test onboarding with a focus on regulatory assistance. Annual CAP/CLIA readiness to provide strategic insights.

Early-stage diagnostics teams don’t fail because they lack effort — they struggle because critical decisions are made too late.
Three River Oaks partners with founders and leadership teams to build regulatory and operational foundations
that hold up under inspection and support long-term growth.
We focus on readiness, clarity, and sequencing — helping labs avoid reactive fixes, reduce inspection risk, and move forward with confidence.
When needed, we also help teams think through how early regulatory and operational choices impact scale and commercialization over time.

Hands-on and practical — Clear action plans, real implementation support, no generic templates. Built for early-stage teams — Senior-level expertise without the cost of a full-time hire.

With 55 years of deep experience in molecular and specialty diagnostics, we provide regulatory assistance and strategic insights to help teams move from concept to launch with clarity, confidence, and regulatory credibility.
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