Regulatory business automation software

Efficiently manage the entire life sciences process — from planning to handling and tracking submissions — with our regulatory business automation software portfolio.

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 authorization 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

 

DXC ToolBox Legal Edition

Develop, modify, and validate documents, create bookmarks and hyperlinks, report metrics, and perform other PDF transformation operations. Bundled with a scan enhancement, redaction, and masking tools, Toolbox provides the features necessary to assembling legal documents. See below to select the bundle that is right for your business.

DXC ToolBox Pharma Edition

Develop, modify, and validate documents, create bookmarks and hyperlinks, report metrics, and perform other PDF transformation operations. This edition focuses on pharmaceutical workflow requirements such as MD5 Checksum, Non-eCTD electronic Submission [NeeS] table of contents [TOC] and the International Council for Harmonization [ICH] verification checker for multi-region submission of regulatory documents. See below to select the bundle that is right for your business.

DXC ToolBox Professional Edition

Develop, modify, and validate documents, create bookmarks and hyperlinks, report metrics, and perform other PDF transformation operations. In addition to the standard tools power your workflow with bookmark master and auto-return bookmarks for the professional touch. See below to select the bundle that is right for your business.

DXC ToolBox Standard Edition

Develop, modify, and validate documents, create bookmarks and hyperlinks, report metrics, and perform other PDF transformation operations. Use 30 tools for all your PDF document processing needs. See below to select the 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.

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



Perspective

How real-world evidence transforms the entire healthcare ecosystem

Real-world data has the potential to break down inefficiencies and fill information gaps throughout the healthcare ecosystem.

Read the paper

Partners and key collaborators

AWS

Modernize, accelerate migrations and create cloud value with DXC and AWS.

Hyland-Alfresco

Seamlessly manage life sciences content, data and workflows on one holistic, unified platform.