PAREXEL’s consulting business segment has launched a new service line designed to provide a focused, market-driven approach to regulatory outsourcing services, with a primary emphasis on post-approval regulatory activities. Through the new offering, the company will customize services for clients based on their needs and business challenges by combining expertise, operational approaches and technology.
"With the ever-changing regulatory environment, pharmaceutical companies face new challenges that need to be addressed with efficiency and cost in mind," said Mark A. Goldberg, M.D., president and chief operating officer, PAREXEL. "PAREXEL is uniquely positioned to provide this new service offering, given our regulatory expertise, global operational capabilities and information management technology. Clients will now be able to outsource significant portions of their regulatory activities to a trusted partner in a cost-effective manner."
"Regulatory outsourcing is growing increasingly important in the market as more and more companies rely on outsourcing to help them with the complex task of managing their regulatory needs, especially the regulatory maintenance of their marketed products," said Rick Riegel, corporate vice president and new head of the PAREXEL Regulatory Outsourcing Services line. "This service offering provides a unique solution that addresses new pressures felt by our clients, allowing them to become more efficient in the area of regulatory operations and affairs."