Paragon launches manufacturing compliance service for drug firms
The service is based around analysis of real-time manufacturing data combined with regulatory knowledge and an industry best practices guide developed by the New Jersey, US-based systems consulting firm.
The aim is to help manufacturers meet the US Food and Drug Administration’s (FDA) increasingly strict quality requirements according to Kevin Lea, Vice President and Client Partner at Paragon.
“Like other health authorities, the United States FDA is pursuing industry standards for quality metrics and the need to collect, integrate and manage manufacturing data has become critical to maintaining a strong compliance position.”
He added that: “Quality analytics measures are increasingly being recognized as key tools for ensuring an uninterrupted supply of medicines and monitoring compliance across industry supply chains.”
Paragon offers services to a wide range of industries, from financial services and insurance to healthcare and life sciences. In the past few years the firm has been redoubling its efforts to provide drugmakers with real-time analytics and monitoring.
In 2011, for example, Paragon teamed up with Bioclinica to provide drugmakers with a more effective way of producing drug supplies for clinical trials.
At the time Paragon’s director of life sciences clinical optimization James O’Keefe told Outsourcing-pharma.com that: “Simulation is definitely a new area [for the drug industry], and still not well established in the marketplace for Clinical Supplies.
He added that: “Forecasting, in one method or another, does occur, but with limited success for optimization of the clinical supply chain.”
