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Clinical affairs main
LDT/CLIA
Our extensive experience with IVD and LDT organizations helps us to deploy best practices for cost effective compliance with the NYSDOH CLEP and FDA requirements.
We can also act as your RA/QA organization to develop, implement, and monitor your quality system for phased-based implementation of the NYSDOH CLEP requirements with your current CLIA quality system.
CLIA/CAP
Development and integration of CLIA/CAP with phased-based integration of FDA QMSR
Single Site Submissions
Developing FDA 510(k) and PMA for LDTs as single site for FDA submissions
NYS - CLEP
Meeting the requirements of New York State - Clinical Laboratory Evaluation Program
CDx/Clinical Studies
Supporting LDT based CDx including
Q-submissions, IDE, 510(k), and PMAs
30 years
Our team members have been serving the life science industry for more than 30 years.
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