Existing internal resources are overloaded with the additional task of product data maintenance, specifically in the dynamic environment of the pharma industry with mergers and acquisitions of companies or product portfolios.
arivis’ team lifts the additional workload from your resources after such events by taking over the effort of data alignment, bulk changes and submission according to the lates regulations.
How we do it
- on demand outsourcing of XEVMPD data maintenance to arivis
- trained arivis employees assess the data and make all necessary changes (technically and content), either in customer system or in GxPD
- we handle all activities in relation to EMA quality control including communication with EMA
Who are our customers
Pharmaceutical Companies with several hundred to thousands of products who want to mitigate workload peaks or do not have enough internal resources for ongoing data maintenance.
Reference: Customer with several thousand products
- data cleansing after acquisition of product portfolio
- QPPV and MAH change
- Handling indication changes after EMA QC review
- communication with EMA