• Software

    EXTEDO to extend its EXTEDOpulse RIM software solution using Generis’s CARA™ foundational content & business process management platform

    EXTEDO, a leading provider of regulatory information management (RIM) software and services today announced that they have selected Generis’s CARA™, a foundational platform for content and business process management, to build out and enhance its EXTEDOpulse RIM solution and support expanding its market beyond Life Sciences. Under the agreement, EXTEDO will become a leading Build Partner for Generis, leveraging the low-code flexibility of CARA, in combination with its own strong industry expertise, to develop new platforms for content, data and business process management. EXTEDO, which has 25 years of Life Sciences industry experience, will harness CARA to rapidly expand its highly-regarded submission management and publishing solutions, enhancing its popular EXTEDOpulse…

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  • Allgemein

    EXTEDO Adds Comprehensive Cloud-Based Document Management System To Their Portfolio

    EXTEDO, a leading provider of Regulatory Information Management solutions, today announced the launch of a complete DMS solution to help their clients with project implementation, planning, preparation, and validation processes. The product addresses critical requirements for submission and validation processes while enabling incremental adjustments to support the demanding needs of life sciences companies. Solutions for the life sciences industry require a highly complex development cycle. Each solution consists of the contributions of many role-players with multiple steps of validation and review. Managing clinical trials, tracking quality processes, and organizing regulatory submissions demand extreme attention to detail, accuracy and consistency. EXTEDO’s eDOCSmanager consists of five modules to take projects from implementation…

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  • Software

    Taiwan FDA Chooses EXTEDO’s Solutions for Validation and Reviewing

    (DATE) – EXTEDO, a leading provider of Regulatory Information Management solutions today announced that the Taiwan Food and Drug Administration (TFDA) have decided to use EXTEDO’s agency solutions to review electronic common technical document (eCTD) submissions in the future. The Taiwan FDA pre-announced the eCTD validation criteria on 16th June 2020 and will follow up this with a formal announcement after they have received feedback from the stakeholders within the Taiwanese medical industry. The Genetics Generation Advancement Corporation (GGA Corporation), has partnered with EXTEDO to support the Taiwan FDA in their introduction of the eCTD standard within Taiwan. Following countries such as the USA, EU, Japan, Australia, Canada and Switzerland,…

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  • Software

    EXTEDO & Wrike announce strategic partnership to release a planning and tracking solution for the life sciences industry

    EXTEDO, a leading provider of Regulatory Information Management solutions and Wrike, a leading provider of cloud-based enterprise collaborative project management software, today announced the release of a new planning and tracking solution to help facilitate a solution for the COVID-19 virus. Wrike is an all-in-one collaborative work management solution that allows its users to manage workflows securely at scale, turn strategies into actionable plans and drive operational excellence. Benefitting from the years of experience with hundreds of Wrike clients, EXTEDO adapted the proven collaborative project management solution to the requirements for pharmaceutical companies and  the life sciences industry, and integrated it with the EXTEDO RIM platform. This allows users to…

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