End-to-End Regulatory Support for BLA Submission with the US FDA

A Korea-based biotechnology manufacturer reached out to Freyr to prepare a CTD for BLA Submission to the US FDA. They needed to develop a sound Regulatory strategy and successfully execute the same to meet their product registration goals in LATAM and APAC countries. Freyr completed the project on time that included end-to-end assistance for generating CMC data following the US FDA requirements and compiling a checklist of each LATAM and APAC country's Regulatory requirements.

Download the proven case study to learn how Freyr implemented solutions to meet Regulatory requirements while successfully meeting deadlines.