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Regulatory business automation software and services

Turn complexity to opportunity by deploying AI and automation across regulatory affairs content, data and workflows.

Life Sciences companies are seeking transformative ways to put the patient at the center of their innovations. The answer lies in digital strategies that truly make the patient the center of innovation and reduce the time to market.

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 Regulatory Information Management (RIM) Platform: Securely integrate and connect compliance components to easily manage all regulatory affairs content, data and workflows on one holistic, unified platform.

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 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.

Questions?

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.

Questions?


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.

Select the number of licenses that your business needs.

Quantity: 1 - 4

$ 4,562.25 USD * (plus a one-time support fee of $ 912.45 USD for the first year)

* price per license

Quantity: 5 - 9

$ 3,878.49 USD * (plus a one-time support fee of $ 775.70 USD for the first year)

* price per license

Quantity: 10 - 24

$ 3,193.58 USD * (plus a one-time support fee of $ 638.72 USD for the first year)

* price per license

Quantity: 25 - 99

$ 2,509.12 USD * (plus a one-time support fee of $ 501.82 USD for the first year)

* price per license

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.

Select the number of licenses that your business needs.

Quantity: 1 - 4

$ 4,562.25 USD * (plus a one-time support fee of $ 912.45 USD for the first year)

* price per license

Quantity: 5 - 9

$ 3,878.49 USD * (plus a one-time support fee of $ 775.70 USD for the first year)

* price per license

Quantity: 10 - 24

$ 3,193.58 USD * (plus a one-time support fee of $ 638.72 USD for the first year)

* price per license

Quantity: 25 - 99

$ 2,509.12 USD * (plus a one-time support fee of $ 501.82 USD for the first year)

* price per license

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.

Select the number of licenses your business needs.

Quantity: 1 - 4

$ 866.25 USD * (plus a one-time support fee of $ 173.25 USD for the first year)

* price per license

Quantity: 5 - 9

$ 736.89 USD * (plus a one-time support fee of $ 147.38 USD for the first year)

* price per license

Quantity: 10 - 24

$ 606.38 USD * (plus a one-time support fee of $ 121.28 USD for the first year)

* price per license

Quantity: 25 - 99

$ 476.32 USD * (plus a one-time support fee of $ 95.26 USD for the first year)

* price per license

DXC Writer

Create regulatory documents by using available templates and increase productivity and reliability.

Select the number of licenses that your business needs.

Quantity: 1 - 4

$ 1,155.00 USD * (plus a one-time support fee of $ 231.00 USD for the first year)

* price per license

Quantity: 5 - 9

$ 981.80 USD * (plus a one-time support fee of $ 196.36 USD for the first year)

* price per license

Quantity: 10 - 24

$ 808.50 USD * (plus a one-time support fee of $ 161.70 USD for the first year)

* price per license

CTD Templates only

$ 13,860.00 USD (plus a one-time support fee of $ 2,772.00 USD for the first year)



Perspectives

Life sciences companies can speed regulatory approval with Gen AI

Pharmaceutical companies get the help they need for automating regulatory information management [RIM] workflows, reducing the potential for errors to appear in documents they are required to submit to obtain regulatory approvals.

Harnessing AI to revolutionize healthcare

Learn about several exciting new AI-related clinical trials and research programs that promise to advance the prevention, diagnosis and treatment of disease.

Leveraging technology supports health equity

DXC strategists discuss about how personalized care pathways are linked to better outcomes and improved patient safety.

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.