Diagnostics Lab Consulting for CAP & CLIA Readiness

 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. 

 Regulatory and operational decisions made early in a laboratory’s lifecycle often determine inspection outcomes later.

Three River Oaks provides advisory support focused on readiness, sequencing, and clarity — helping diagnostics teams avoid reactive fixes, reduce regulatory risk, and build inspection-ready operations that scale. Our services are designed to meet teams where they are, from early concept through inspection preparation and growth.

Our Advisory Services

Three River Oaks provides experienced advisory support to help diagnostics laboratories make the right regulatory and operational decisions early — before inspection pressure and timelines tighten.

We work with early-stage and growing labs across:

CLIA & CAP Readiness
Inspection preparedness, regulatory interpretation, and operational alignment to support successful inspections and ongoing compliance.

Laboratory Operations & Quality Systems
Design and strengthening of laboratory operations, workflows, and quality management systems that scale and hold up under inspection.

Assay & Test Development (CLIA-Regulated)
Support for LDT validation, molecular and immunoassay development, and analytical validation aligned with CLIA expectations.

FDA Regulatory Strategy
Strategic regulatory guidance across development, validation, and submission to reduce risk and support efficient progression toward approval.

 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.