BioPharma Services, Inc. Successfully Completes 3 FDA Inspections with ZERO Form 483’s

Autor: BioPharma Services, Inc.
Zdroj: Business Wire (English). 05/26/2017.
Abstrakt: BioPharma Services, Inc. (BioPharma) is proud to announce that it has successfully completed 3 inspections this month by the US FDA, with concurrent audits at both research centers in Toronto, Canada, and Columbia, Missouri. Over the course of 2 weeks, the back-to-back inspections focused on a total of 9 studies including 4 bioanalytical validations that were conducted in support of ANDA and NDA filings to the US FDA. All 3 inspections concluded without a 483 Form being issued as BioPharma continues to build on its impressive regulatory track history with zero observations. [ABSTRACT FROM PUBLISHER]
Databáze: Regional Business News
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