MPDmanager

MPDmanager (Registration Management Hub) is a regulatory information and master data management solution developed by EXTEDO, designed for life sciences organisations managing medicinal product registrations across multiple markets. Powered by CARA, it centralises IDMP, XEVMPD, PMS, and core product data in a single platform, supporting compliance with regulatory requirements and enabling electronic submissions to health authorities. The solution is aimed at regulatory affairs teams dealing with large volumes of product registrations, complex data maintenance obligations, and the ongoing transition from XEVMPD to IDMP.

MPDmanager is built around the principle that product data should be entered once and reused across all related authorisations and regions. Changes made to core product data — such as formula or composition — automatically propagate to all related and affected products, reducing duplicate data entry and minimising the risk of inconsistencies. The platform also covers the management of authorisation details for medical devices.

Core Data Management Capabilities

• Centralised management of IDMP, XEVMPD, and core (CORE) medicinal product data in a single platform
• Single-entry model: identical product information such as formula or composition does not need to be re-entered per market authorisation or region
• Automatic propagation of data changes across all related and affected products
• Management of authorisation details for medical devices in addition to medicinal products
• Built-in business, technical, and internal validation to assure data reliability and quality
• Overview of all marketing authorisations held across the organisation
• "Where Used" functionality to maintain transparency and track relationships between documents, submissions, and products

IDMP and XEVMPD Compliance

• Native integration with the EMA PMS database, supporting both download and upload of PMS (IDMP) data
• Compare functionality to align internal company product data with EMA PMS data and identify discrepancies
• Supports the transition from XEVMPD to IDMP by allowing access to submission data without requiring comprehensive knowledge of every technical detail
• Uses the EMA SPOR database for up-to-date controlled vocabulary
• Receives agency acknowledgement reports (1st, 2nd, and 4th ACK) within the same application, linked to relevant product information
• Integrated business rules validate data against the latest specification before submission
• Integrated gateway enables automated submission directly to regulatory agencies

AI Capabilities (AIxpt)

• AI-assisted search across product, activity, and collaboration data to reduce time spent locating information
• Ability to search for data within already existing documents using AI functionality
• Regulatory Intelligence (RI) Module uses AIxpt to review and combine existing documents to answer regulatory queries
• Accurate translations into multiple languages supported by AI
• Intelligent comparison tables to facilitate data verification across markets
• All AI methods are fully auditable

Regulatory Intelligence (RI) Module

• Centralised hub for managing Health Authority Documents and regulatory intelligence data
• Supports comparison of regulatory intelligence data across different markets
• Import and export functionalities for integrating external information and sharing insights across teams
• Designed to support informed, data-driven regulatory decisions

Regulatory Activity and Submission Integration

• Supports transfer of regulatory activities, dossiers, submissions, and document attributes to eSUBmanager
• Automatically links transferred items to relevant change requests and products or applications within change control processes
• References Master Data Management and Controlled Vocabulary to ensure consistency across all hubs
• Reuse of data across hubs minimises errors and maintains a single source of truth

Integration with EXTEDOpulse Solution Suite

• Can be used as a stand-alone registration management solution or combined with other EXTEDOpulse hubs
• Integration with the Document Management Hub (DMS Hub) allows users to store, access, and manage regulatory documents and reports
• Integration with the Submission Management Hub enables creation of dossiers linked to planned activities based on data held in MPDmanager

Available Services

• IDMP Services: specialist support for organisations transitioning from XEVMPD to IDMP, drawing on EXTEDO's regulatory knowledge and experience
• Education and Training: tailored training sessions covering technical and regulatory topics, delivered in-house or onsite
• Technical Consulting: support for correct installation, implementation, and integration of the solution

EXTEDO has provided regulatory software solutions to organisations worldwide for over 25 years. MPDmanager is part of the broader EXTEDOpulse platform and is supported by additional services including validation services, extended support, and business process consulting. The solution is designed to address compliance risks associated with incorrect or outdated medicinal product data, with the goal of reducing manual regulatory administration effort.