An Asia-based mid-sized pharmaceutical company sought to launch a generic anti-hypertensive drug in the U.S. market.
With limited internal expertise in FDA submissions and facing a tight launch timeline, the client needed end-to-end support for ANDA preparation, compilation, and submission.
Vigilare’s Regulatory Affairs team provided end-to-end support including regulatory strategy, technical file preparation, labeling/packaging compliance, and direct liaison with health authorities.
Key achievements included completing the dossier preparation and submission within a twelve-week turnaround, ensuring first-cycle acceptance of the ANDA with no Refuse-to-Receive (RTR) from the USFDA. Vigilare streamlined internal documentation
processes, reduced the client’s effort by sixty percent, and secured an on-track U.S. market entry for a generic antihypertensive drug, establishing a template for future regulatory filings.
Download the case study to see how Vigilare enabled faster approvals and global market reach
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