List of consulting services for your lab:
1. CLIA, CAP, and COLA Application & Accreditation
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.
2. Inspection Readiness
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.
3. Test Validation
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.
4. Document Control and SOP Writing
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.
5. MolDX Application and Technical Assessment
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.