Regulatory Support in Filing ANDA Amendments and IND - LCM Submissions

A top US-based pharmaceutical company sought Freyr's support for filing ANDA amendments and IND-LCM submissions with the USFDA.

Freyr's Publishing & Submissions (P&S) team successfully addressed challenges and delivered high-quality output within tight timelines. They conducted multiple quality checks on frequently changing documents and implemented a 24X7 global delivery model.

Download the case study to learn how Freyr achieved error-free submissions and helped the customer meet Regulatory objectives.

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