Case Study: a leading biopharmaceutical company achieves submission-ready labeling compliance with FREYR

Leading Biopharmaceutical Company achieves 10-hour labeling TAT with FREYR

A leading biopharmaceutical company faced challenges in maintaining regulatory compliance for its labeling documents across multiple regions, including the US, UK, Canada, Australia, and the EU. The client needed a partner to meticulously proofread, format, and review documents like the CDS, SmPC, and USPI to meet specific regional health authority requirements and overcome language barriers. They engaged FREYR for its regulatory text review and formatting support services.

FREYR implemented a comprehensive solution that involved proofreading all labeling documents against source materials and applying meticulous formatting. Using internal checklists developed for different regions, FREYR delivered submission-ready documents with a 100% right-first-time accuracy and a turnaround time of approximately 10 hours per document. This streamlined process from FREYR ensured rapid, high-quality completion, enhancing efficiency and fully meeting the client's regulatory compliance expectations.