As per Article 57 of European Medicinal Agency (EMA) it is mandatory for all marketing authorization holders (MAHs) and sponsors of clinical trial to submit product information to xEVMPD (Eudravigilance Medicinal Product Dictionary) database. Our technology platform, process accelerators and regulatory expertise enable you to Receive, Validate, Manage and Facilitate the end to end process of product submission to EU agency.
Product data management for multiple medicinal products registered in numerous different regions involves significant effort, it can be a time consuming and costly process. Our technology and solution experts help you manage the current product submission requirements and work with you to define road map for transitioning into evolving ISOs Identification of Medicinal Products (IDMP) standards.
Key Product Features
- Validates information about excipients and adjuvants and their concentrations within the finished product along with the printed product information. It also validates technical substance information for which clarifications are still pending from EMA
- Help regulatory people maintain regulatory information and Pharmacovigilance people maintain Pharmacovigilance information, and where interested parties throughout the organization can have ‘read only’ access to both, can bring huge benefits in terms of visibility of the product portfolio, key timelines and resource planning generally
- The solution comes with an e-submission gateway as an add-on option to enable secure and automatic e-submission via gateway. Also, it can be easily integrated with your existing e-submission gateway
- Easily integrate with your internal and external data source systems such as product master, external data from CRO/ CMO partners
- Our configuration and validation services assist customers in completing the configurations and validation specifications
How Do we Deliver
Compier XEVMPD is a component of our Compier platform. It can be deployed on its own or in combination with other modules of the platform.