The client is a U.S. based integrated pharmaceutical company specialized in topical drugs. The client was looking to partner with a Regulatory expert to file compliant and accurate ANDA submissions to the USFDA. The challenge was to track all changes and make the revisions in eCTD format.
Download the case study to decode Freyr’s approach of filing compliant ANDA submissions with zero errors.
Fill the form below to download the Case Study