EXTEDOpulse Submission Viewing

EXTEDOpulse Submission Viewing is a web-based tool designed for life sciences organizations that need to view, review, and track regulatory submission content and metadata. It is part of the EXTEDOpulse Submission Management Hub and is aimed at regulatory affairs teams, global affiliates, and other stakeholders who work with electronic submissions in formats such as eCTD v3 and v4, without necessarily having deep eCTD expertise.

The tool addresses common challenges in submission review workflows, including difficulty identifying changes across an application's lifecycle, limited collaboration between internal and external stakeholders, inability to review eCTD v4 submissions via fileshare, and time spent manually locating regulator-approved information. EXTEDOpulse Submission Viewing provides a centralized, browser-based environment to address these issues.

Application and Submission Management

• Provides a centralized view of the entire structure of submissions, accessible through a standard web browser without requiring specialist software.
• Delivers a unified overview of all folders, documents, and metadata from multiple sources and stakeholders, across all submission formats.
• Supports both eCTD v3 and v4 submission formats, enabling review of new and legacy structures.
• Allows users to search for applications and documents based on metadata, reducing time spent locating relevant content.
• Offers a global application overview, including regional submissions compiled by local affiliates.

Collaborative Review Capabilities

• Enables optimized document viewing and mark-up without requiring users to download entire documents.
• Supports real-time collaborative mark-up, allowing stakeholders to make and share suggestions without editing original content directly.
• Allows simultaneous commenting, document checking, and lifecycle version comparison across departments and global locations.
• Includes performance-tuned rendering so that large files load quickly.
• Provides visual side-by-side comparison that clearly highlights updates, deletions, and additions between submission versions.
• Supports annotation across a range of content formats, including PDFs, Word documents, and videos.
• Includes a "Where Used" feature that reveals document relationships across multiple medicinal product applications, supporting impact tracking and consistency management.

Generative AI Reviewing Assistance

• Integrates Generative AI capabilities that allow users to interact with submission content in eCTD format through a real-time chat interface within documents.
• Retrieves information from a secure, compliant knowledge base, reducing the time needed to locate specific details within submissions.
• Each AI-generated response includes traceable links to the source document, related application, and sequence number.
• Data is stored securely and accessible only for this dedicated use case, with full GDPR compliance.

Master Data and Hub Integration

• When used alongside other EXTEDOpulse Hubs, reviewers gain access to a complete overview of regulatory activities, submission content plans, document attributes, and applications.
• Master data is reused across all Hubs, supporting data quality and alignment with organizational data governance policies.
• Provides transparency into what external publishers and internal teams are working on across the submission lifecycle.

Available Supporting Services

• Business Process and Regulatory Consulting: workshop-based consulting to establish business needs, understand existing processes, and define an appropriate implementation approach for eCTD submissions.
• Education and Training: tailored training sessions covering technical and regulatory topics, delivered in-house or onsite, for each product in the EXTEDOpulse portfolio.
• Technical Consulting: support for correct installation, implementation, and integration of the solution within an organization's environment.

EXTEDOpulse Submission Viewing is a component of the broader EXTEDOpulse platform, which also includes hubs for document management, registration management, safety management, and quality management. EXTEDO states that its solutions have been used by organizations and regulatory authorities worldwide for over 25 years.