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The only CRO to offer cGMP manufacturing in a U.S. Phase I clinical research unit
September 28, 2015
By: Tim Wright
Editor-in-Chief, Contract Pharma
Covance Drug Development is set to open a cGMP-compliant pharmacy at its clinical research unit in Madison, WI, allowing for on-site production of high quality, customized pharmaceutical products for clinical trials. Covance, which opened its first cGMP pharmacy at its Dallas, TX facility earlier this year, is the only CRO to implement cGMP standards for Phase I manufacturing of investigational drug products in a U.S. Phase I clinical research unit. The Madison cGMP pharmacy will be available for client audits beginning in October. Small-scale cGMP manufacturing meets the highest regulatory and safety standards and lowers the cost to manufacture pharmaceutical products for clinical trials. Covance’s facilities offer certified clean rooms that support a full range of sterile manufacturing, including aseptically prepared sterile parenteral investigative drugs and radiolabelled doses, as well as non-sterile investigational drug products. “With dedicated pharmacists, production teams, and direct cGMP quality assurance oversight, Covance provides industry-leading quality and cost-effective manufacturing services with greater flexibility to help clients meet their Phase I clinical trial needs,” said Herman Scholtz, vice president and general manager, early clinical services, Covance. “These new drug development solutions demonstrate our commitment to providing innovative and differentiated solutions to streamline and enhance clinical trials, bringing innovative medicines to patients faster, and helping change the way care is provided.”
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