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Regis Completes Successful Audit

Gains approval of Control Testing Lab

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By: Kristin Brooks

Managing Editor, Contract Pharma

Regis Technologies, Inc. has successfully passed an FDA audit with no Form 483 observations. Regis’ GMP manufacturing facility, QC lab, and quality systems were part of a detailed inspection that found the company to be in compliance with the agency’s cGMP standards.   Regis provides synthesis, separations and manufacturing services to pharma and biopharma companies for intermediates and APIs from process development and scale-up, through validation and commercial manufacturing, from its cGMP fa...

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