CAP/CLIA Regulatory Assistance and Capabilities
At Three River Oaks, we specialize in providing top-tier CAP/CLIA Regulatory Assistance for your laboratory. Our expert team is dedicated to helping you achieve your goals and improve your operational excellence and can assist with New Laboratory Set Up and Laboratory Developed Tests (LDT).
Regulatory Assistance
Regulatory Capabilities
Regulatory Capabilities
TRO is well-versed in regulatory requirements for CLIA/FDA pathways for diagnostic assays and devices and can evaluate your project and needs and assist in these steps towards approval or compliance.
- Molecular/Immunoassay
- Laboratory Developed Test (LDT) – CAP/CLIA
- Assay Review
- Protocol Development
- Sample Procurement
- Validation Design
- Laboratory Developed Test (LDT) – CAP/CLIA
- Emergency Use Only (EUA)/510(k) FDA
- Assistance related to the analytical testing portion of the project
- Assistance with the stability testing both accelerated and standard
- Assistance with the clinical testing portion of the project
Regulatory Capabilities
Regulatory Capabilities
Regulatory Capabilities
TRO has extensive capabilities and experience with regulatory requirements associated with service and clinical diagnostic laboratories.
- Research Use Only (RUO) Development and Support
- Laboratory Determined Tests (LDT), Optimization, Validation, and Technology Transfer
- FDA Emergency Use Authorization (EUA) Development, Optimization, Validation, and FDA Submission Support
- SOP Development
- Protocol Development
- FDA 510(k) Development, Optimization, Validation, FDA Submission Support
- Protocol Support (Benchtop testing and Clinical Trial)
- Pre-Submission Support
- FDA Meeting and correspondence support