ESM Portal

Provides functionality for pharmaceutical companies that market products in the EEU to comply with the European Medicines Agency (EMA) requirement for submission of information on Medicines by marketing-authorization, holders

European Pharmaceutical

After the European Union’s 2010 pharmacovigilance legislative decision, the push began for stricter requirements in European pharma labeling and submissions. The European Medicines Agency (EMA) responded by establishing a requirement that all documentation relating to pharmaceutical products be submitted for review via electronic submission to meet EMA standards through the EudraVigilance data processing management system, XEVMPD. As always, Intagras closely monitored these developments as these requirements rolled out across Europe, looking for opportunities to help those pharmaceutical companies actively marketing products across the continent.

Our response to these requirements was the release of Electronic Submission of information on Medicines (ESM) Portal. ESM Portal is available as an on-premise, or as a SaaS subscription, and offers European pharma marketing-authorization holders the powerful and flexible feature set that is the hallmark of every Intagras application, but applied to dealing with product labeling and e-submissions mandated by the EMA standards. ESM Portal provides data entry, management, and submission life-cycle functionality to European pharma marketing-authorization holders seeking an accurate and error-free method of ensuring compliance in their product information management and submission efforts.

With the power to support unlimited country locations, milestones and end-users, ESM Portal is the premier choice of leading pharmaceutical companies placing a high value on compliance and accuracy while instilling greater effectiveness and efficiencies in their workplace.

As an industry leader in providing high quality software and services to the pharmaceutical industry, Intagras understands that working within the confines of the European Medicines Agency’s pharmacovigilance laws and regulations is, at times, difficult. ESM Portal simplifies that task, freeing you to concentrate your energies and resources on other tasks, knowing your labeling and submissions are compliant, accurate and error-free.   
For more information, or to schedule a demonstration, call Intagras at (813) 226-1863.