The client was a USA-based pharmaceutical and manufacturing company seeking support in the filing of general correspondence for ANDA submissions to the USFDA. The challenges with this project were the availability of lesser time and tracking versions of frequently changed documents for eCTD submissions. Freyr, with its expert resource pool, was able to validate large volumes of documents in the given time and make the submissions with zero errors. Freyr took care of the client’s end-to-end publishing needs and helped in the lifecycle management of their products.
Decode how Freyr was able to successfully submit ANDA correspondence to the USFDA and ensure that the client met its Regulatory objectives in a compliant manner. Download the proven case.