The client was a UK-based leading global innovative biopharmaceuticals company who was seeking Regulatory assistance from Freyr in filing original and Life Cycle Management (LCM) submissions to the MHRA. The project presented several challenges such as stringent deadlines, maintaining the lifecycles of all their products, filing ad hoc original and LCM submissions to the MHRA, and coordinating with the Chemistry, Manufacturing, and Controls (CMC) team for published documents.
Freyr’s Publishing & Submissions team addressed all the challenges and filed the submissions with zero errors and warnings. The customer was able to file original applications, promotional labeling for Biological License Applications (BLAs), safety reports, Periodic Advanced Drug Experience Reports (PADER), general correspondence, requests, and responses to queries.
Know more about how Freyr helped the client meet their business requirements within defined timelines and ensured the ad hoc filing of original and LCM submissions to the MHRA with zero errors. Download the proven case.