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.
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