The client was a USA-based pharmaceutical company looking for Regulatory support in filing LCM submissions for ANDA. Freyr had to work in defined timelines while offering support in end-to-end publishing activities and filing ad hoc submissions to the USFDA. Freyr’s Publishing and Submissions experts addressed the challenges and achieved 100% accuracy in the submissions. The team created a detailed tracker to help the client track all the version changes made in the documents during the publishing process.
Decode how Freyr filed multiple LCM submissions for ANDA with zero errors and warnings, while taking care of extensive publishing activities for the client. Download the proven case.