Validation Edge, LLC helps clients with developing compliant, quality systems that are easy to monitor and control. We strongly believe that the quality systems should work for our clients and not the other way around.
The importance of regulatory compliance and quality assurance in FDA regulated industry is paramount.
Our team of quality experts assist our clients in Pharmaceutical, Biotechnology, Medical Device, Diagnostic and Active Pharmaceutical Ingredients (API) industry with developing, implementing and maintaining compliant quality systems that are tailored to our clients' specific needs.
We specialize in helping clients with Remediation of FDA's Warning Letters and 483 observations.