Freyr was approached by a leading American generic pharmaceutical company looking for proven Regulatory support to help them compile, review, and submit an annual report of ANDA to the USFDA. Through proactive follow-up, initiation of gap analysis, and authoring the annual report, the Freyr team ensured timely communication, finalization, and submission to USFDA.

Discover how the client successfully achieved their ANDA annual report submission goals and business continuity in the USA market. Download the proven case.