Pharmaceutical Business review

Eisai signs three-year contract extension for CSC’s Total Regulatory Solutions as-a-Service

The deal expands the ongoing life sciences software and cloud-hosting services CSC is delivering to Tokyo-based Eisai’s US pharmaceutical subsidiary until December 2019.

CSC has been providing regulatory information management (RIM) solutions and business process services to Eisai since 2012.

RIM helps in simplifying Eisai’s management and submission of the data needed by regulatory agencies in various countries to secure approvals to market drugs.

The drug maker utilizes the entire stack of CSC’s TRS software products hosted on CSC CloudCompute.

The move will support document management, publishing and regulatory submissions to the US Food and Drug Administration and other regulatory agencies globally.

Eisai president of global regulatory affairs Martina Struck said: "Combining CSC’s TRS solution and Eisai’s global regulatory processes enabled several submissions to occur in multiple markets simultaneously."

Eisai Strategic Information Systems vice president and Americas IT director Dan Utzinger "CSC’s solution aligns to our IT strategy of moving aggressively to the cloud."

CSC’s TRS allows companies to choose to either outsource all of their regulatory operations functions or scale those functions in order to suit their requirements.

TRS features a range of delivery models that allow increased third-party collaboration, secure compliance and provide safe worldwide support.


Image: CSC Headquarters in Falls Church, Virginia. Photo: courtesy of CSC.