MasterControl, a provider of enterprise quality management systems, and Lorenz Life Sciences Group, a regulatory information management solutions provider, have a decade of joint success when it comes to customers streamlining and integrating their document and submission management services.
“Integrating with an industry leader, MasterControl, has been providing a seamless way for customers to drag-and-drop documents that are stored and managed in the MasterControl documents module. This allows users to easily build an Electronic Common Technical Document (eCTD) submission in docuBridge,” said Yaprak Eisinger, managing director, of Lorenz North America. “Our partnership with MasterControl aligns with our goal to streamline the e-submission processes for companies and regulatory agencies around the world.”
Lorenz docuBridge will be integrated with MasterControl v 11.6 with the release of 5.10. This is the natural evolution of integration with previous MasterControl releases v9, v10 and v11. In recent updates, MasterControl introduced new APIs, which enabled Lorenz to better integrate its functionality with features that were not available in previous versions. One of the key new features is the ability to use document property values from MasterControl to automatically populate eCTD attributes including manufacturer, substance, product and study Number. Customers will also be empowered to more easily compile their eCTD submissions by flagging items in MasterControl at any time that will need to be part of the submission.
“The Lorenz docuBridge is a well-established system for small, medium and large companies to compile, publish, manage and review electronic submissions,” said Patricia Santos-Serrao, RAC, director of clinical and regulatory solutions of MasterControl. “Leading health agencies in Europe as well as Health Canada have been using Lorenz docuBridge to view incoming submissions for many years, and last October, the FDA awarded them a contract to be FDA’s eCTD validation and review software as well. Partnering with Lorenz was a solid strategic move to enable our mutual clients a streamlined method for submissions such as new drug applications, investigational new drug applications, master files and so on to regulatory bodies.”
Lorenz docuBridge complies with all global eCTD standards, NeeS, VNeeS, AMNOG, paper submissions and more.
MasterControl
Lorenz Life Sciences Group
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