The client, one of the leading Hungary based, leading Excipients Company had a requirement of compiling, and preparing DMF Amendments into electronic CTD format and submit to FDA and TPD. The client had lack of understanding on requirements for DMF submissions and eCTD submission requirements. Freyr had a hard time to get responses from clients for review and data support. Still Freyr successfully prepared the DMF Amendments as per FDA and TPD guidelinesbased on the source data.
How was the client benefitted from Freyr’s services and solutions? Read the case study.