We help clients identify and develop the ideal laboratory space. Whether building a new lab from the ground up or retrofitting your existing one, we'll find the best solution based on your needs. In addition, we partner with instrument manufacturers and vendors negotiating the best equipment & reagent contracts to support a smooth, compliant launch.
We provide comprehensive Medical Director placement and oversight services tailored to each laboratory’s test menu and operational needs. Our team screens and places qualified laboratory directors based on their specialty and experience, ensuring the right leadership fit for your testing scope. We thoroughly review credentials to confirm compliance with all federal, state, billing, and regulatory requirements. By aligning expertise with your lab’s complexity and focus, we help maintain accreditation standards, strengthen oversight, and support long‑term operational success.
Our specialized consulting services streamline the CLIA and CAP application and accreditation process. We guide laboratories through every stage of regulatory compliance, ensuring alignment with the highest quality standards. Our team manages documentation, communication, and readiness reviews so the process moves efficiently and accurately—allowing your lab to begin testing and pursue reimbursement sooner. We verify all submissions for completeness and compliance, minimizing delays and positioning your laboratory for successful accreditation and long‑term operational excellence.
Our test validation services ensure your assays meet the highest standards of accuracy, reliability, and compliance. We design validation protocols aligned with federal, state, accreditation, and billing requirements to prevent downstream setbacks. Our team has extensive experience validating oncology‑focused NGS and PCR assays, ensuring efficient study design, clean documentation, and readiness for accreditation and reimbursement.
Effective document control and Standard Operating Procedures (SOPs) are essential for maintaining quality and compliance in laboratory settings. Our services provide customized SOP writing that aligns with your specific operational needs and regulatory requirements. With our expertise, you can establish robust document control systems that support your lab's efficiency and compliance goals.
Our Inspection Readiness services include comprehensive mock inspections designed to simulate real regulatory assessments, helping you identify potential gaps and areas for improvement. We provide detailed inspection reports that outline findings, recommendations, and actionable steps to enhance your readiness.
We streamline your reimbursement pathway through payer credentialing, MolDX applications, and billing workflows. We help define and document clinical utility, the evidence Medicare and commercial insurers rely on for coverage decisions. We also mitigate claim denials and provide an initial reimbursement readiness assessment to identify gaps and next steps. For international companies, we offer targeted risk‑mitigation strategies to align with U.S. payer expectations.
Open today | 09:00 am – 05:00 pm |
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