Suppliers of XEVMPD Software

Liquent’s InSight for XEVMPD is a software application that allows users to create and maintain product data, create compliant submissions, and processes agency acknowledgements in support of Article 57 of the new EU pharmacovigilance legislation.  The intuitive, web-based solution can leverage data from Liquent’s InSight for Registrations, part of the Liquent’s Regulatory Information Management Platform, and will be upgradable to support the future ISO IDMP standard.

INFOTEHNA’s eMPDExpert^TM is a module of INFOTEHNA myPharma Expert Suite^TM 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.

Virtify offers an intuitive, web based system for creating and managing xEVMPD data and the full submission lifecycle. Data can be extracted from existing databases and loaded directly into Virtify EVMPD, manually gathered using pre-defined spreadsheets, or entered through the web interface. Data and the EVMPD submission is validated against vocabularies, business rules and the EMA published schema. An in-house or hosted solution, it is updated for ongoing compliance, including under IDMP in 2015

Nanokinetik’s READY!™ for Article 57is a web-based solution for the collection and maintenance of regulatory information for human and veterinary products. READY!™ supports automatic submissions in XEVMPD format through the EV Gateway.

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.

CSC Life Sciences (now incorporating the former ISI organisation) will provide an extension to their TRS Tracker regulatory information management system.

EXTEDO’s web based MPDmanager^TM can be used as a stand-alone solution as well as a master data sharing platform combining information from different sources (including other EXTEDOsuite components as well as third party products). It allows companies to easily enter, import, share and submit all relevant regulatory master information and can be used as in-house or hosted solution. With the underlying data model, MPDmanager^TM is ready for the future by supporting XEVMPD and already being IDMP compliant.

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.

Intagras’ ESM Portal provides marketing-authorization holders the ability to create, validate, and generate XEVPMD submission in minutes. ESM Portal application was built specifically for the EMA’s article 57 initiative and provides the easiest most intuitive approach to creating and maintaining data. ESM Portal can be install on-site and integrated with legacy systems or accessed via our Software-as-a-Service (SaaS) model. Your team can be generating compliant submissions immediately. Intagras also provides submission creation services via our outsource model.

DREAM was co-developed by the regulatory consultancy AccepTher and the Regulatory IT provider SolDRA Intl. Their solution is a complex Regulatory Information Management and process tracking system, and includes an optional ESTRI gateway adapted for xEVMPD reporting. When implemented in enterprise environment it completes, without re-defining, established internal working procedures, and provides a suitable solution for Regulatory life-cycle management and maintenance of Article 57 compliance. It has a robust IT platform, for which is independent from other database licences or expensive Document Management Systems; as such is a suitable tool for third party xEVMPD service providers

The XEVMPD maintenance and transmission system -iris- is a solution of PHARMSOFT Dr. B. Rodust GmbH, Germany. -iris- includes currently the last version of SSI and version 3 of EV business rules. New pool data and new business rules update automatically via the internet and are immediately available. -iris- is characterised by following features: user-friendliness, excellent performance, XEVMPD data can be imported as well, navigation tree automatically shows available forms, easy and fast coding with MedDRA® in all levels, intelligent transmission reminder, available as multi-core database.