250,000 global users
Efficiently manage the entire life sciences process — from planning to handling and tracking submissions — with our regulatory business automation software portfolio.
The way life sciences businesses and regulators collaborate to bring safe new therapies to market is ripe for transformation. Digitalization and automation offer speedier creation, submission and querying of the volumes of documentation inherent in research and commercialization. This DXC-sponsored paper discusses the digital-first approaches to the automation required for the industry.
Life sciences companies are seeking transformative ways to deliver better health outcomes. The answer lies in digital technologies that will accelerate innovation and reduce time to market for new therapies and devices.
Our software suite gives life sciences companies the tools they need to accelerate innovation and reduce time-to-market for new therapies, devices and medicines. DXC’s proven expertise helps customers improve business agility and operational efficiency.
250,000 global users
70,000 regulatory submissions with zero refusals by regulatory authorities
15,000 pharma products approved and managed
100% of Fortune 500 pharma companies are DXC customers
DXC Total Regulatory Solution Suite: Simultaneously publish and submit new drug applications in multiple markets and in compliance with a variety of regulatory formats. Built with a single user interface, this suite includes eCTDXPress, Publisher, Viewer, validation and administration modules.
DXC Life Sciences Connected Platform: Securely integrate and connect compliance components to easily manage all regulatory affairs content, data and workflows on one holistic, unified platform.
DXC FirstDoc™: Support research and development (R&D), Quality and Manufacturing (Q&M) and Quality Management System (QMS) with simple navigation, task management and collaboration.
DXC Tracker: Managed regulatory information management (RIM) to plan and track drug approvals, maintain compliance, and streamline submission and market authorisation activities.
Technical support questions? Mail to: trssupport@dxc.com
DXC ToolBox: Develop, modify, and validate documents, create bookmarks and hyperlinks, report metrics, and perform other PDF transformation operations. DXC Toolbox has editions supporting legal, pharma, professional and standard operations. See below to select the edition and bundle that is right for your business.
DXC Writer: Create regulatory documents by using available templates and increase productivity and reliability. See below to select the bundle that is right for your business.
Technical support questions? Mail to: trssupport@dxc.com
Purchasing DXC Writer licenses through the online store is for the Writer ToolBar only, and only for existing DXC Writer customers who have already purchased the Writer CTD Template Package. If you have not already purchased the Writer CTD Template Package, please contact your DXC Account Manager.
No DXC Account Manager? Mail to: trssupport@dxc.com
Real-world data has the potential to break down inefficiencies and fill information gaps throughout the healthcare ecosystem.