Proven Labeling Expertise for USPI, PIL Creation, Review, and SPL Review

A US-based generic pharma company needed submission-ready labels for ANDA filings. With increased turnaround time for resolving internal subject matter expert-related enquiries and with the slow pace of compliance implementation, there were delays in label creation and review. Freyr supported the client in reorganizing internal labeling workstreams while keeping tab on HA audits.

Decode how Freyr achieved Regulatory compliance and 100% right first-time submission while developing and reviewing USPI, PIL documents along with providing SPL review.

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