LDT Consulting
LDT Consulting
At Elite Lab Consulting we provide support for:
- New York Application Submission
- Regulatory Compliance
- Validation Packet Review
- FDA Compliance
At Elite Lab Consulting, we have over 25 years of experience in Laboratory Developed Tests.
LDT (Laboratory Developed Test) consulting services help laboratories navigate complex regulatory requirements and ensure compliance with federal and state guidelines.
New York Submission Support assists labs in preparing and submitting required documentation for approval by the New York State Department of Health.
FDA Compliance services help labs align with FDA regulations for LDTs, ensuring proper classification and adherence to guidelines.
Regulatory Compliance consulting provides expert guidance on CLIA, CAP, COLA, and state-specific requirements.
Validation Packet Review ensures that all necessary documentation, including test validation data and quality control measures, meets regulatory standards for accuracy and reliability
Contact Us
Whether you’re looking for guidance on regulatory compliance, operational efficiency, specialized testing services, or starting a laboratory, our experienced consultants offer the support you need to succeed in a competitive and regulated industry.
contact@elitelabconsulting.com
