Gateway Analytical Registers With US FDA
Gateway Analytical showed confidence in its quality system, a collection of policies, procedures, plans, and supporting infrastructure documenting control over all activities, for pharmaceutical analysis with its recent registration with the US FDA. As a laboratory conducting high-quality tests for drug manufacturing companies recognized by the FDA, Gateway Analytical took a necessary step by registering. All companies registered are eligible for full-facility inspections at any time.
“This registration with the FDA demonstrates our commitment to our quality system, which is the basis of all of our analytical testing services,” said David Exline, Senior Vice President of Gateway Analytical. “Our goal is to take the same approach with regulatory entities in other industries that we serve.”
Gateway Analytical complies with current good manufacturing (cGMP) standards and is currently implementing procedures conforming to guidelines compliant with 21 CFR Parts 210 & 211, ISO/IEC 17025:2005, ISO 9001:2008 and ASCLD/LAB-2006 Supplemental Requirements. The analytical lab specializes in pharmaceutical and industrial forensics, particle identification and characterization, and criminal trace evidence examination services.
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