LDT/CLIA

Laboratory Developed Tests (LDTs)

Cost-effective and tailored approaches to implement the FDA LDT rule

Our extensive experience with IVD and LDT organizations helps us to deploy best practices for cost effective compliance with the LDT rule.

We can aslo act as your RA/QA organization to develop, implement, and monitor your quality system for phased-based implementation of the LDT rule with your current CLIA quality system.

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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

Our experience is our key asset and building trust is our goal!

30 yrs

Our team members have been serving the life science industry for more than 30 years.

100%

return and retention rate

We are proud that we are able to build and trust with our clients and retain of clients for multiple years.

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