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Owing to their specialized nature, BLAs require complete attention to detail. Moreover, gap analysis, submission strategy, and preparation for the US FDA require an expert like Freyr.
The client had a limited understanding of the Regulatory operations and of Module 1 requirements. With complete understanding and timely support from Freyr’s Regulatory Affairs and Operations team, the submission was made in a timely manner to the US FDA. Download the proven case now.
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