The right solution for the right task across the life science’s process life cycle

DXC’s Regulatory Business Automation Software portfolio uses automation to simplify document creation and the submission process, creating efficiencies and shortening cycles.

Organizations also benefit from DXC’s global reach and vast experience in regulatory submissions, which helps guide companies through every step of the complex regulatory submissions process.

Plan, Track and Manage

The regulatory affairs and operations departments of life sciences companies are under intense pressure to handle submissions and manage information and data around the regulatory process. Having information at their fingertips that can contribute to efficient and effective decision making is invaluable from both regulatory and commercial perspectives. Moving product information across the continuum of internal and external constituents across the life cycle of drug development requires the ability to plan, track and manage.

• DXC Tracker: Gain control over regulatory submission information

Author and Approve

DXC's suite of life sciences regulatory content management solutions brings together some of the industry's most innovative document, data and regulatory management tools to help life sciences companies succeed in today’s complex regulatory and commercial environments.

• DXC Life Sciences Connected Platform: Easily manage all regulatory affairs content, data and workflows on one holistic, unified platform
• DXC FirstDoc^TM: Market-leading electronic document management system (EDMS) designed for the life sciences industry
• DXC Writer: Streamline the medical writing process with templates that help you save time while ensuring guidance compliance

Build and Publish

DXC’s regulatory publishing software suite provides an end-to-end solution that empowers users to assemble, review, compile and publish dossiers — such as electronic common technical documents (eCTDs) and non-eCTD electronic submissions (NeeS) that meet various requirements.

• eCTDXpress: Make eCTD submissions faster and easier by streamlining the process: from building and compiling to validating and archiving
• Publisher: A scalable solution that can be implemented on premises or in a cloud environment, can simplify the submission process
• DXC ToolBox: Simplify the time-consuming tasks involved in producing and processing PDF files

Access, View and Navigation

Information access sometimes presents challenges for the life sciences industry, but having data immediately available and in one location can be invaluable during the regulatory submission process. For example, information from archived dossiers might well be helpful in the handling of in-process electronic Common Technical Documents (eCTDs) or in addressing agency queries. Distributed teams, varying infrastructure, different roles and tasks, and yet DXC pulls this altogether so that our customers can readily Access, View and Navigate their critical product information with our Viewer product.

• Viewer: Versatile document viewer brings regulatory information together in one location
• DXC FirstDoc^TM: Market-leading electronic document management system (EDMS) designed for the life sciences industry