Case Study: a US-based multinational company achieves eCTD compliance in EAEU with FREYR

a US-based multinational company achieves 100% quality and zero errors with FREYR

A US-based multinational company faced challenges ensuring eCTD submission compliance in the EAEU region, including complex regulations, a lack of local regulatory expertise, and dissatisfaction with their existing vendor. FREYR provided expert consultation and transition support to move from paper to electronic XML submission formats.

FREYR implemented a strategy that included offshore publishing and support services, successfully transitioning over eight products and executing more than fifteen submissions. This solution ensured 100% quality with zero errors and rapid turnaround times, leading to swift approvals for the client and the successful submission of a Marketing Authorization Application (MAA) within the stipulated timeline.