ELC Group, the pan-European pharmaceutical regulatory affairs organisation, today announces the launch of a new subsidiary, Pharma eReport – a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals.
Pharma eReport offers a total package for Marketing Authorisation Holders (MAHs) seeking to meet the July 2nd 2012 deadline for mandatory EudraVigilance Medicinal Product Dictionary (EVMPD/XEVMPD) data submissions. With its flagship Centrality software suite and specialist EVMPD services – delivered by a Key Support Services team of qualified chemists – Pharma eReport provides a comprehensive EVMPD solution, including complete outsourced data-gathering and compilation of Structured Substance Information (SSI) libraries. The Centrality software is available as an on-demand software-as-a-service (SaaS)/cloud-based solution – accessed via a standard web browser – or it can be installed as a standalone software application. Centrality is offered via a transparent pricing model and will be in full general availability from March 2012. Prospective users are invited to sign up online now for priority product demonstrations.
Pharma eReport’s Centrality software tool allows MAHs to quickly and effortlessly convert existing medicinal product information into an XML Schema Definition (XSD)- compliant format, and seamlessly upload the required data as a EudraVigilance Product Report Message (EVPRM) using an approved submission mechanism. The software is secure, easy to use and custom-engineered for flexible implementation, including development support for bespoke interfaces to provide full harmonisation with customers’ existing systems.
Pharma eReport’s Centrality platform provides an intuitive product license management system for database-wide pharmacovigilance updates, tracking, organising and managing product and substance information, and ensuring continuing EMA regulatory compliance. Centrality can be coupled with specialist Key Support Services – including data collation, organisation and mapping capabilities, plus complete SSI library compilation services – to enable customers to extract maximum value from substance data.
Pharma eReport is co-founded by the management of ELC Group plus former executives from electronic design automation software company Synopsys, Inc. Pharma eReport harnesses the unparalleled industry knowledge of its regulatory expert founders and combines this with a world-class software development team to deliver a total solution for EVMPD compliance and beyond.
Commenting on the solution launch, Marco Rubinstein, CEO of ELC Group and Pharma eReport said: “We are launching our new subsidiary and the Centrality solution to deliver the full service solution that regulatory teams need to meet the time-critical EVMPD compliance challenge. We’ve designed a uniquely flexible, transparently-priced software solution which can be supported by our highly skilled service organisation of qualified chemists and, crucially, access to our key SSI library resources. For regulatory teams, we are reducing the admin burden and providing an easy-to-use software platform that creates a valuable centralised product license and information database for future use.” He continued: “Beyond the immediate 2012 deadline, all MAH submissions will soon need to comply with a coming ISO IDMP (Identification of Medicinal Products) standard, expected to be in force by 2015. So pharmaceutical companies that are selling or marketing medicinal products in Europe will need to implement an effective e-reporting solution now, to reduce the MAH submissions management overhead and ensure seamless ongoing regulatory adherence. We’re looking forward to becoming the industry’s key solution partner for EVMPD compliance – and beyond.”