TORONTO--(BUSINESS WIRE)--BioPharma Services Inc. (BioPharma) is proud to announce that its Toronto-based clinical and bioanalytical site for Phase I/IIa clinical trials and bioequivalence studies has successfully completed an audit by the U.S. Food and Drug Administration (FDA). This was BioPharma’s 4th inspection by the FDA (2008, 2009, 2012 and 2015) and the 1st inspection of the bioanalytical laboratory unit. The audit was conducted from June 1st to June 5th as a Pre-Approval Inspection for ANDAs submitted. The inspection confirmed that the clinical and bioanalytical facilities were in compliance with the principles and guidelines of GCP. No Form 483 observations were issued. This is BioPharma’s 3rd consecutive FDA inspection without Form 483 observations.
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