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Synomics Successfully Completes FDA Audit

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has completed an inspection of Synomics Pharmaceutical Services’ facilities and operations in Wareham, MA. The inspection included both PAI and general regulatory compliance, as Synomics Pharma had been named in three NDAs. No 483’s were issued.
   
John Pirro, vice president and chief operating officer of Synomics Pharma, said, “The positive inspection of our facilities and operations by the FDA attests to the strength of our comprehensive quality management system. Our highly trained scientists and industry experts, led by Dr. Kirk Smith, director Quality Systems, have worked together to develop a fully integrated GLP and cGMP quality system that assures reduced regulatory risk without adding inefficiencies or costs. Further, this system integrates the principles from recent FDA and AAPS initiatives for bioanalysis for clinical trials, bridging the regulatory requirements from preclinical to commercial development.”

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