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We can help – introducing Centrality

We provide a comprehensive EVMPD and Article 57 (2) compliance solution for Marketing Authorisation Holders.   Our Centrality software tool has been designed by pharmaceutical regulatory industry experts to enable pharmacovigilance and regulatory affairs teams to quickly and easily submit information to the EVMPD.  Centrality enables you to 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 system enables organisations to create a complete, centralised product information database for future use, and provides integrated, intuitive capabilities for managing ongoing updates to product information.

Our software is secure, easy to use and custom-engineered for flexible implementation.  Centrality 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.  We offer development support for custom interfaces to provide full harmonisation with your existing systems.

The system provides a comprehensive solution and complete product license database for managing pharmacovigilance data updates, tracking and managing submission information, and ensuring continuing EMA regulatory compliance.

A complete solution: Key Support Services

The Centrality solution can be coupled with our Key Support Services to ease the administrative burden and enable Marketing Authorisation Holders to extract maximum value from collected substance data.

Our expert team of qualified chemists can provide data collation, data entry and data checking services, including fully outsourced data-gathering and the compilation of complete Structured Substance Information (SSI) libraries.

Total XEVMPD compliance solution

Centrality software

  • Designed by RA experts

  • Secure, easy-to-use, standards-compliant

  • Transparent pricing options

  • Flexible deployment – cloud, intranet or standalone access


Key Support Services

  • Delivered by qualified chemists
  • MA data collation & entry
  • Excel spreadsheet import/export
  • XML import/export
  • Updating of messages to V5 schema
  • Custom software integration interfaces

View our Centrality brochure

Centrality software

Key Support Services

FAQ

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We have also made available an excel spreadsheet for data entry. If you prefer to enter your data in excel, then use this spreadsheet and we will be able to import, check and convert the data to compliant XML.

Download excel