From 2011 till 2016 Kern Pharma doubled the number of products in its range. Within their regulatory department, a customized internal database was used for tracking all the registrations and processes. However, it was a challenge to maintain this in-house Regulatory Information Management System and keep it up-to-date and compliant. With more products, they also found it increasingly difficult to track the status of their currently approved regulatory products. In addition, the internal tool provided limited integration possibilities with other platforms (e.g eCTD publishing, DMS, SAP, LIMS, etc.). The additional complexity was the management of processes, which was done with Excel spreadsheets.
The implementation of RImanager allowed Kern Pharma to have a single data source for all regulatory products and processes. This has greatly improved their control and use of data. The potential connection between their regulatory data and other IT tools will further support the company’s mission to improve the quality of day-to-day life through its products.
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