SOURCE: Synomics Pharma

July 17, 2008 10:30 ET

Synomics Pharma Successfully Completes FDA Audit

WAREHAM, MA--(Marketwire - July 17, 2008) - Synomics Pharmaceutical Services, LLC, a leader in bioanalytical, stability and analytical testing services for the pharmaceutical industry, announced today that the U.S. Food and Drug Administration (FDA) has completed an inspection of its facilities and operations in Wareham, Massachusetts. The inspection included both PAI and general regulatory compliance, as Synomics Pharma had been named in three NDAs. No form 483 was issued.

Synomics Pharma, a Smithers Group company, provides a broad portfolio of services in support of drug development and production. "Our successful inspection by the FDA exemplifies Smithers' commitment to continually provide our clients with a quality service that goes above and beyond the industry standard. Our quality management system allows our clients to be very confident in the reliability and integrity of their data," said Michael Hochschwender, President and CEO of The Smithers Group. "Smithers is dedicated to improving the value of our offerings, and we aim to consistently surpass regulatory requirements."

John Pirro, Vice President and Chief Operating Officer of Synomics Pharma, noted, "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 pre-clinical to commercial development." For more information about Synomics Pharma's customized solutions, visit or call 508-273-0450.

About Synomics Pharma

Synomics Pharma, a leading global Contract Research Organization (CRO), specializes in customized, full-service compliance solutions for the pharmaceutical, personal care, and allied industries. Based in Wareham, Massachusetts, USA, the company's quality system has been globally recognized by authorities as an industry benchmark. Visit for more information.

Contact Information

  • Press Contact:
    Hope Aubin

    Synomics Pharmaceutical Services LLC
    790 Main Street
    Wareham, MA 02571-1037