Rapid Application Integration and 21 CFR Part 11 Compliant Hosting
SUMMARY
In order to meet their first FDA submission deadline a spin-off division of a large life science company needed to implement Electronic Document Management Systems (EDMS), electronic Common Technical Document (eCTD)solutions to manage their documents, clinical trial information, and FDA submissions. The division had a corporate directive to file their initial NDA (New Drug Application) with the FDA in less than a year. Due to already overstretched resources, the corporate IT department would not be able to initiate an evaluation or begin the implementation of EDMS and eCTD solutions for at least one year.
Court Square Group (CSG) implemented and hosted multiple applications within CSG’s Audit Ready Compliant Cloud™(ARCC) environment and provided a fully functioning submission environment in less than three months. Court Square Group’s solution enabled the client to implement, train and submit the necessary documentation to the FDA for their first approval even earlier than the anticipated deadline.
THE CLIENT
The client is a new pharmaceutical start-up division of a large medical device manufacturer that was tasked with producing the first pharmaceutical products for the company. The client had a drug candidate that they intended to bring to market within the year.
