MPDmanager - Regulatory Information and Master Data Management Solution

Simplifying the management of IDMP, PMS, XEVMPD, medicinal product information, and regulatory activities in a single solution.

Easily manage all your product information in a single platform

Assure data reliability and quality via built-in validation

Efficiently maintain XEVMPD and IDMP data

Can you keep up with regulatory requirements?

A growing volume of registrations gets increasingly more difficult to maintain in compliance with regulations.

I am overwhelmed by the data maintenance requirements of IDMP
We are unsure about the impact on marketing authorizations a change will have
I am worried about using incorrect data
We struggle to keep up with product changes and stay compliant

We are missing an overview of all the marketing authorizations we have in the company
We struggle to keep the entire company in compliance
I am concerned about changes in availability due to manufacturing obstacles
I am overloaded doing repetitive updates on the same product for different regions

Managing product data in compliance with XEVMPD and IDMP should be effortless

Data reliability

Make sure your data is correct with business, technical and internal validation.

Single source of truth

Easily manage all your medicinal product information in one platform.

Stay compliant

Manage all the IDMP, XEVMPD and CORE data relating to your regulated products.

Connect to agencies

Use the EMA SPOR database to receive agency reports linked to relevant product information.

For over 25 years, EXTEDO solutions have been used by organizations worldwide to streamline the management of their regional product registrations.

"EXTEDO is a great example of a company that really understands the requirements of the market."

Director Business Development,
Technical Operations and International Business at Genericon

Your plan to effortless compliance

Schedule a call

We’ll discuss your goals and uncover your challenges with your medicinal product data management and registration.

Get a free consultation

Identify opportunities to improve your current product data management.

Manage your medicinal product data effortlessly

Gain full transparency of your medicinal product data and transform hundreds of hours spent on regulatory administration into a matter of clicks.

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

Every life sciences company is concerned that incorrect or outdated medicinal product information may put the health of patients at risk and cause product recalls.

MPDmanager powered by CARA provides a way to effortlessly manage worldwide product registration data, enabling you to minimize compliance risks and trust that the data you rely on is accurate and up-to-date.

A single solution for thousands of registrations

MPDmanager powered by CARA 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. Additionally, MPDmanager covers the management of authorization details of medical devices. Overall, MPDmanager saves you time, prevents duplicate data, and creates clarity throughout the compliance process for effortless validation and approval.

Unlock the power of AI in Regulatory Information Management

The AI feature in the EXTEDOpulse Registration Management Hub supports your regulatory teams in leveraging their data to facilitate searches, collaboration and the creation of new information. The EXTEDOpulse AIxpt offers fully auditable methods to maximize the use of information in your repositories.

In MPDmanager, AIxpt enables targeted searches across product, activity and collaboration data, saving time and reducing errors. In the Regulatory Intelligence (RI) Module, AIxpt reviews and combines existing documents to answer your queries. Accurate translations into different languages as well as intelligent comparison tables, make data verification easier and more efficient than ever.

Connect directly to regulatory agencies

MPDmanager comes with integrated business rules to validate data before submission based on the latest specification. The integrated gateway allows 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 & 4rd ACK) in the same application linked to the relevant product information.

Download, compare and submit IDMP data to PMS

MPDmanager has native integration with EMA PMS which allows download as well as upload of PMS (IDMP) data within EMA PMS Database. With the compare functionality you can immediately compare the EMA PMS data with the internal company product data and ensure alignment and consistency of company 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 authorities.

Simplify global regulatory compliance

MPDmanager's Regulatory Intelligence (RI) Module is a powerful solution, designed to simplify the complex world of regulatory compliance across different markets. This module offers a centralized hub for managing Health Authority Documents and RI Data, making document organization and retrieval effortless. With the RI module you can easily compare Regulatory Intelligence Data, helping you identify similarities and differences across various markets. Integrate all the external information you need and share insights with your team, thanks to seamless import and export functionalities. You'll experience increased efficiency in your regulatory processes, improved compliance management, and the ability to make informed, data-driven decisions.

Streamlined regulatory activity transfer

Using EXTEDOpulse allows you to efficiently transfer regulatory activities, dossiers, submissions, and document attributes to eSUBmanager. Automatically link these to relevant change requests and products/applications within change control processes while referring to Master Data Management and Controlled Vocabulary. Reusing data ensures consistency across all Hubs and minimizes errors, providing a single source of truth. The "Where Used" functionality enhances transparency and maintains relationships between documents and submissions in the Document Management Hub and Submission Management Hub.

Connection to the EXTEDOpulse solution suite

EXTEDO’s MPDmanager works as a stand-alone Registration Management solution or can be combined with other EXTEDOpulse hubs using the same system. Through its automations with the DMS Hub, users can store, access, and manage regulatory documents and reports for easy processing. These automations also extend to the Submission Management hub, where dossiers can be created and linked to planned activities based on the information available in MPDmanager. With EXTEDOpulse, the possibilities sare limitless.

Some of our Customers

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.

Education & Training Services

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. Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or onsite.

Technical Consulting

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.