On-time BLA Submissions to US FDA

A leading global healthcare consulting firm based in the USA approached Freyr to assist them with the BLA submission, including converting documents into the format required by the US FDA. In addition to the content and format-related challenges presented from the client-side, there was a need to speed up the processes to gain the product approval on time. Freyr offered a 24x7 global delivery model to meet strict schedules and successfully executed document conversions as per the ICH specifications.

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