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MPDmanager - IDMP Software and Master Data Management Solution

A single source of truth for your IDMP, XEVMPD and other medicinal product data.

To bring a product to market, stringent regulations and thousands of registrations present a formidable task for life sciences organizations. MPDmanager powered by CARA is the solution you need for all of your pharmaceutical product registrations.

Registering product information for each region and every update is a time consuming and costly process involving human resources, data organization and administration expertise. EXTEDO’s MPDmanager is a comprehensive master data management (MDM) solution that enables you to effortlessly manage all the IDMP, XEVMPD and CORE data relating to your regulated products.

With MPDmanager, you gain the ability to create, update and reassign core product data for each product at once. You can send electronic submissions directly to the relevant authorities, enabling you to fulfil your regulatory requirements and get to market faster - no matter the region.

Benefits

Assure data reliability and quality via business, technical and internal validation.

Guided dictionary maintenance through standard or custom regulatory activities.

Supports future demands such as multi-gateway functionality.

A single, easily managed source of truth for all your medicinal products.

A single solution for thousands of registrations

MPDmanager is specifically designed to keep your core product data organized and aligned. Product data only has to be added to the system once. Identical information such as the formula or composition of one product does not have to be added per market authorization and region. Now you can transform hundreds of hours spent on regulatory administration into a matter of clicks so you can focus on product development rather than data management and regulation.

Maintain your data the easy way

Every component that makes up your pharmaceutical products affects its validity for different approval agencies. With MPDmanager, you can see authorizations for any changes and the products affected throughout your system. Simply change the data in the core product and the edit will reflect automatically on all related and affected products. MPDmanager saves you time, prevents duplicate data, and creates clarity throughout the compliance process for effortless validation and approval.

Connect directly to regulatory agencies

MPDmanager comes with integrated business rules to validate data before submission for all standards based on the latest specification. The integrated gateway allows semi-automated submission directly to the agencies. MPDmanager uses the EMA SPOR database to work with up-to-date controlled vocabulary and receives agency reports (1st, 2nd & 3rd ACK) in the same application linked to relevant product information.

Simplifying the move from XEVMPD to IDMP

MPDmanager is the most efficient solution to transition from XEVMPD to IDMP. The ability to access submission data without comprehensive knowledge of every detail makes the transition smoother while ensuring your business continues to remain compliant into the future. It improves your data quality, increases operational efficiency, and delivers better-automated communication channels between your departments and with authorities.

Integrated part of the EXTEDOpulse platform

EXTEDO’s MPDmanager works as a stand-alone Registration Management solution or can be combined with other EXTEDOpulse hubs using the same platform. Through its connection to the DMS Hub, users can store, access, and manage regulatory documents and reports for easy processing. It can also integrate with EXTEDO’s extensive Planning and Tracking Hub, for more detailed resource and task planning/ tracking. Or, through its seamless integration with the Submission Management Hub, it can link dossiers to planned activities based on available information in MPDmanager. With EXTEDOpulse, the possibilities are limitless. 

Resources

Services

IDMP Services - Ensuring a successful transition from XEVMPD to IDMP

Is our company able to meet the latest IDMP requirements?

This is the question that a lot of organizations are asking as they get ready for the transition from Extended Eudravigilance Medicinal Product Dictionary (XEVMPD) to Identification of Medicinal Products (IDMP). EXTEDO's services team is well-equipped with the knowledge and experience to help your organization transition painlessly from XEVMPD to IDMP.

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