The following companies are offering XEVMPD solutions. Inclusion here does not infer any endorsement from Marr Consultancy Ltd.
INFOTEHNA’s eMPDExpertTM is a module of INFOTEHNA myPharma Expert SuiteTM targeting the EMA’s EVMPD requirements. It is a web-based solution for management of EVMPD information, assembly and submission of XEVPRM to EMA, with an intuitive desktop look and feel.
NNIT’s solution for their EasyMPD editor to deliver either as a Cloud solution hosted in their GxP environment or as an on-site system.
ArisGlobal’s agXchange RSM module is a stand alone application which is connected out of the box to Register but can be connected to any tracking system. It provides a fully automated end-to-end solution including management of the acknowledgements and the EV codes returned by the EMA application.
Lorenz will provide an XEVMPD solution as an extension to their drugTrack regulatory information management system.
Samarind have updated their Regulatory Management Software to incorporate the new requirements for XEVMPD. The previous version of this regulatory information management system provided support for the ‘old’ EVMPD. There are two versions, for Windows (on-site) and a web based On-Demand version.
Mission3’s GlobalTrack GxPD is a Microsoft SharePoint 2010 based solution that supports meeting the new EMA xEVMPD requirements. This web application supports companies to manage and submit Product and SSI information in a simple way. One of our unique features is the connectivity to any available source system (eDMS, ERP/SAP, etc.) to reduce re-keying activities and increase compliance. Extended reporting and workflow functionalities are also part of the solution. The design of the system allows to get started now.
Freyr’s EVMPD is an easy-to-use, hosted On-Demand and onsite deployable web-based solution for EVMPD information management including content authoring and XEVMPD conversion with state-of-the-art navigation/User interface components, context sensitive helpful hints, granular authoring and customizable data import & export capabilities.
Pharma eReport’s Centrality software tool provides a comprehensive solution for EVMPD compliance and beyond. The software is available via flexible deployment options – secure cloud, on-site intranet or standalone application. Centrality enables regulatory affairs teams to securely upload XML Schema Definition (XSD)-compliant product data, efficiently track compliance activity, and create a valuable centralised product information database for future use. We offer development support for custom interfaces to provide full harmonisation with your existing systems.
With their product PvNET EVPRM, Sarjen Systems are providing an XEVMPD solution that can be either deployed on premises or available as hosted solution.
TrackWise by Sparta Systems is a leading enterprise quality management solution that is used today by global organizations seeking to automate the product registration process. TrackWise supports electronic reporting standards including eMDR, eMDV, CTR, and e2b and Sparta Systems is working with customers in preparation for meeting the regulatory reporting needs of EVMPD as the standard matures.