Our specialized consulting services streamline the application and accreditation process for CLIA, CAP, and COLA. We guide laboratories through regulatory compliance, ensuring adherence to the highest quality standards. With our expert support, you can navigate complex requirements efficiently, enhancing your laboratory’s credibility and operational excellence.
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.
Our test validation services ensure that your laboratory methods meet the highest standards of accuracy and reliability. We follow strict regulatory guidance to develop tailored validation protocols that confirm the precision and reproducibility of your tests.
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.
We provide expert guidance on MolDX applications, helping you prepare and submit documentation for coverage of molecular diagnostic tests. Our thorough technical assessments ensure that your tests meet all necessary criteria for clinical validity and utility. With our support, you can confidently navigate the MolDX landscape, optimizing your chances for successful approval and reimbursement.
As the regulatory landscape for Laboratory Developed Tests (LDTs) evolves, navigating FDA submissions will become increasingly complex. Our team is at the forefront of these changes, offering expert guidance to ensure your LDTs comply with the latest requirements. We assist you in preparing and submitting comprehensive documentation that meets FDA standards, helping to streamline the approval process. With our knowledge and experience, you can confidently address regulatory challenges and position your tests for success in a dynamic environment.
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