CLIA / CAP / NY State Lab Services

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Our LDT (Laboratory Developed Test) development consultants  provide expertise and support to laboratories that create their own diagnostic tests. This can encompass a variety of areas, including:

1. Regulatory Guidance: Consulting on compliance with FDA regulations and CLIA (Clinical Laboratory Improvement Amendments) requirements for LDTs.
2. Test Design and Development: Assisting in the scientific design of the test, including the selection of methodologies, reagents, and platforms.
3. Validation Studies: Offering insights into the design and execution of validation studies to ensure the test's accuracy, precision, and reliability.
4. Technical Documentation: Helping with the creation of necessary documentation, such as SOPs (Standard Operating Procedures), validation reports, and regulatory submissions.
5. Quality Control and Assurance: Providing guidance on implementing quality control measures and establishing a quality management system.
6. Market Analysis: Evaluating market needs and competition to aid in the strategic positioning of the test.
7. Education and Training: Offering training resources for lab personnel on new tests and procedures.

If you're considering developing an LDT or need consulting services, it's beneficial to work with experts who have experience in laboratory processes and regulatory landscapes. Let us help you design and validate your LDT and IVD tests while shortening development timelines and costs.  We have experience in all testing platforms: 

• PCR
• NGS
• ELISA
• miRNA
• Micro Array
• Gene Expression
• Cytology
• FISH

Our team of exerts can help you with all aspects of your medical device development and validation projects.  

• Expertise and Experience: Allow our team's deep understanding of medical device regulations (FDA, EU MDR, ISO 13485, etc.) and years of experience help you drive  successful validation projects.
• Comprehensive Validation Services: We will outline the scope of your validation work, including design validation, process validation (IQ, OQ, PQ), software validation, test method validation, and more.
• Risk Mitigation and Compliance: Our services help clients minimize the risk of regulatory setbacks, ensure compliance, and avoid costly delays or recalls.
• Efficiency and Time Savings: W will help you streamline your validation processes, accelerate time-to-market, and optimize resource allocation.
• Customized Solutions: We will develop tailor validation strategies and protocols to the specific needs to you and your devices.