VITALIC

The need for technology-embedded regulatory services is important as it streamlines laborious regulatory activities to deliver efficiency for regulatory submissions. This reduces 1) time-to-market, 2) cost & resource expenditure, and 3) risk of non-compliance. Vitalic® offers its users a unique combination of project management with document management and regulatory information management system; it facilitates project management by allowing efficient project allocation to resources, multiple levels of project working, and allows complete tracking & monitoring of projects on real time basis all while maintaining a complete Audit trail. Vitalic® supports document management by allowing working on project related individual documents- reviewing, commenting, authoring- and allows the use of Microsoft Office Apps & Adobe Acrobat. It also creates reports on the status of projects, associated documents, and creating completed template-based database of working documents. Additionally, for regulatory information management, Vitalic® helps in creating a repository of regulatory information database which includes country/region-based regulatory guidelines, regulations, evaluation trends by agencies, and agency queries database from prior agency experience. The LifeCycle Management hub of Vitalic® provides all registration information on one platform, reduces manual efforts by 80%, helps in developing a robust regulatory strategy for target markets and prevent business loss on account of regulatory negligence all while maintaining 100% compliance. DDReg's web-based proprietary tool, Vitalic® provides the comprehensive regulatory support that a company needs to penetrate their target markets, in terms of efficient document management, submission management, and regulatory information management, on one platform, at the click of a button.