Managing XEVMPD (Article 57) submissions
Qdossier has created and maintained 6K+ authorised products in XEVMPD since 2011. Our data stewards support in data collection, extractions, cleansing, transformation and entry. Due to our experience in Product- and registration tracking and submission management, we have a comprehensive understanding of regulatory activities and related processes.
Data management services
We offer a one-stop-shop and can provide EMA certified human resources, take care of data extraction, prepare submissions, submit updates to the European Medicines Agency (EMA). Furthermore, upon receipt of third acknowledgement messages, our staff can address EMA QC findings, define follow-up actions and manage updates of records and supportive document, as appropriate. We are software independent and can work with both EVWEB and any vendor solution. Alternatively we can host your XEVMPD data and take care of the submissions using our in-house tool.
Our data stewards can align internal records and databases with EVWEB data to synchronize the current view on data present at both the European Medicines Agency (EMA) and the Company. We can also share our expertise through training and workshops
XEVMPD Software as a Service
Qdossier offers a highly secured SAAS environment to manage your XEVMPD submissions, either as an intermediate solution or for a longer period of time. A client specific working environment can be rapidly deployed and is accessible via a secure two-way authentication process from any location that has an internet connection. Affiliates and partners can be provided with system access to review and approve the XEVMPD output created by your own staff or the Qdossier team. Standard operating procedures and training materials are available to support the entire process of data management and submissions.
Article 57 Background
All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date. This is a legally binding requirement from the EU pharmaceutical legislation. The Agency uses this information to support the analysis of data, regulatory activities and communication.
The aim of the submission of data is to establish a complete inventory of all medicines authorised for use in the EU and EEA, including medicines authorised centrally via the EMA and those authorised at national level. More information can be found on the EMA website.