DXC FirstPoint ™ Regulatory Information Management

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

DXC provides 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.

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 FirstPoint™ RIM.AI: DXC has created five modules to accelerate and optimize regulatory workflows with AI:

• Document Classification: Classify documents automatically when imported into your document management system such as eTMF documents based on their content and metadata to identify the right documents for your use cases within your document management system.
• Document Generation: Generate documents in multiple languages using Generative AI based on sets of source documents and data. Starting with MS Word Module 2 Summary documents for regulated medical submissions, the Document Generation module can be used to generate batches of draft documents from style templates to accelerate your Document Authoring processes.
• Document Validation: Quality check your MS Word documents into PDFs with automated features such as automatic blank page removal, bookmark and link validation and Automatic Redaction of Personally Identifiable Information (PII) such as names of people.
• Content Planning: Create and track content plans such as medical submissions with the ability to automate creation of content through our Document Generation and Document Classification modules.
• Content Authoring: Author content with structured content authoring using prompt templates pulled from Content Planning to automatically start your documents off with and enables multiple authors to work on multiple sections in a single document whilst also offering simplified eDMS capabilities.

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.

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.

DXC Regulatory Services: DXC’s Regulatory Services team has delivered more than 71,000 submissions for the United States, Europe and the rest of world (“ROW”) without a single Refusal to File (RTF). DXC offers full end-to-end services and flexible solution models to address client needs, such as high-peak coverage, process outsourcing and accelerated project needs.

DXC Professional Services: DXC also has a suite of professional services including Digital Transformation Service, Validation and Product Support Services and Consulting.

Bill of Materials: Amazon SageMaker Amazon Bedrock AWS Code Build AWS Certificate Manager Amazon CloudWatch AWS CodeCommit Amazon CodeDeploy AWS Direct Connect Amazon EC2 Amazon Kendra AWS Lambda AWS Managed AD Amazon RDS Amazon S3 AWS Systems Manager Fleet Manager