Product Registration Planning & Tracking

EXTEDO currently is one of the few vendors in the market offering a complete RIM (Regulatory Information Management) solution; the EXTEDOsuite covers the whole regulatory landscape from submission publishing and lifecycle management to pharmacovigilance management to document management to product registration and planning.

MPDmanager

MPDmanager is our comprehensive XEVMPD knowledge base system and the integral part of the EXTEDOsuite. It provides the functionality of a central product data repository and enables you to manage and maintain XEVMPD data efficiently and in compliance with current regulatory requirements. With MPDmanager you regain control over your product data!

MPDmanager will enable you to a) get your data back from EVWeb, b) generate reports, c) perform maintenance operations such as updates and company-specific amendments, and d) resubmit updated reports to the XEVMPD data base.

MPDviewer

MPDviewer enables you to get your data records back from EVWEB and generate reports. MPDviewer is a free of charge web based application. No software needs to be installed or configured on your local systems.

The key feature of MPDviewer is its innovative dashboard. The dashboard presents report results graphically and provides at-a-glance information on statistics. Data, report results, and statistics on authorized products are prepared and visualized in graphs and maps providing a quick and easy overview of your most significant data, both geographically and with regard to contents.

RImanager

EXTEDO / Werum RImanager is a centralised Regulatory Information Management System (RIMS) that enables you to efficiently plan and track the regulatory activities, processes, submissions and commitments related to your entire portfolio of products.

RImanager manages all your product master data. Regulatory activities can be defined that store and track the information related to each product and its related submissions. It can also integrate tightly into your manufacturing processes. This ensures that information regarding labelling, composition, formulation, and drug safety remain in a single repository, allowing instant access for your end-users and providing essential management and regulatory reporting capabilities.

Customer Quote

“Our decision for the EXTEDO tools was based on its intuitive user interface, complete set of capabilities, as well as its wide range of customization possibilities. We appreciate EXTEDO’s focus on maintaining compatibility with the ever increasing amount of electronic standards and processes present in regulatory affairs, such as eCTD, pharmacovigilance and labelling.”

Michael Schaub, Business Development Director of ASPHALION