A UK-based, leading innovator pharmaceutical company was looking for Regulatory assistance for the submission of an original NDA application to the USFDA. The scope of the project was to track all the revisions submitted by the customer, meet the Regulatory requirements of the USFDA and align with them.
Freyr’s Publishing & Submissions team worked collaboratively with global teams to help with the immediate objective of the original NDA application to the USFDA. The team created MBR reports by merging different PPQ executed BMR & forms for IP, DS, and DP, and assisted the customer with the original NDA submission by providing 24X7 Regulatory support under quick TAT.
Learn how Freyr assisted in end-to-end publishing activities and efficiently managed to increase the cost benefits by 70% for the customer. Download the proven case.