Gateway Analytical Registers with U.S. Food and Drug Administration
PITTSBURGH, June 16, 2011 — 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 U.S. Food and Drug Administration (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, 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.
For more information on Gateway Analytical, its quality system or services, visit the company website at www.gatewayanalytical.com. For service inquiries, call (724) 443-1900 or email info@gatewayanalytical.com.
Media Contact:
Suzanne Cibotti
Sr. Marketing Communications Specialist
Tel: 412.241.7335, ext. 291
Email: cibottis@gatewayanalytical.com
Based in Gibsonia, Pa., Gateway Analytical, LLC partners with companies in need of high-quality laboratory analysis that do not have the time, resources or capabilities for specialized, comprehensive testing. Through conventional and innovative testing methods, the company provides expert laboratory services and analytical solutions for the pharmaceutical, forensic and materials science industries. Gateway Analytical is a subsidiary of ChemImage Corporation, a leader in chemical imaging technology and instrumentation.
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