Case Study: a US generic pharma company achieves regulatory compliance and efficient labeling support with FREYR

US Generic Pharma Company achieves 100% right-first-time labeling submissions with FREYR

The US Generic Pharma Company, a USA-based generic pharmaceutical company with a portfolio of complex molecules, faced challenges managing its active product portfolio and lacked in-house regulatory expertise. This made it difficult to handle health authority queries and ensure compliance, so they sought a partner for end-to-end labeling support. They engaged FREYR for its labeling support services.

FREYR provided comprehensive end-to-end labeling support tailored to the US region, managing SPL activities, artwork updates, and publishing. FREYR's solution achieved 100% right-first-time submissions, maintained quick turnaround times, and delivered an exceptional response rate to health authority queries, ensuring full regulatory compliance for the client.