Warnex Inc. has reported that its Bioanalytical Services division successfully passed a Good Clinical Practices (GCP) inspection by the Austrian Agency for Health and Food Safety (AGES). The inspection was a routine, study-specific inspection of a bioequivalence study whose objective was to evaluate the organization's adherence to the applicable regulatory requirements.
"This positive outcome demonstrates once again Warnex's continued commitment to the highest level of quality in all of our laboratory operations," said Mark Busgang, President and CEO of Warnex. "In addition to our successful inspections by the FDA in our Bioanalytical division, Warnex has now added a successful inspection by a European health authority, which we intend to leverage in our business development efforts in the European market."
AGES (www.ages.at (http://www.ages.at) ) is an Austrian government organization, composed of 18 federal institutes and departments with various areas of expertise, which is responsible for several tasks in regards to public health, including nutrition and the safety and effectiveness of medications. The organization researches, analyzes and performs inspections according to the policy guidelines of Austrian food laws and medication laws.