The client is a Switzerland based fastest growing pharmaceutical company and had to file of 5 variations for cefazolin sodium (injection and infusion). It was also planning for re-formatting of the complete dossier for product in Switzerland within a week’s time. Within short time-frame, Freyr was able to perform a detailed Gap Analysis and found 2 new variations.
How performing the Gap Analysis helped Freyr and the client to identify the new variations and how it helped in minimizing the risks? Read the case to know it all.