A single source of truth for your IDMP, XEVMPD and other medicinal product data.
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.
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.
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.
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.
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.
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.
EXTEDO’s MPDmanager simplifies the process of maintaining IDMP and XEVMPD data, delivering a single source of truth of your medicinal product information. Efficiently fulfil regulatory requirements and manage product data, better.
IDMP is the new ISO standard for the unique identification of medicinal products. It enables consistent documentation, coding and exchange of product information - but is it a liability or an opportunity for your organisation? Find out here.
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.
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.