Case Study: a Dubai-based healthcare company achieves successful SFDA registration of Paclitaxel Phares with Freyr Solutions

a Dubai-based healthcare company achieves successful SFDA registration of Paclitaxel with FREYR

A Dubai-based healthcare company sought to register its pharmaceutical product, Paclitaxel Phares, in Saudi Arabia but faced the complex challenge of navigating the stringent Saudi FDA (SFDA) regulations. They required expert support for regulatory strategy, dossier compilation, and submission management to achieve timely market access. They partnered with FREYR for comprehensive regulatory affairs consulting and product registration support.

FREYR conducted a regulatory gap assessment, prepared a compliant CTD dossier, and managed the end-to-end submission process. This solution enabled the successful SFDA registration of the product. The results included accelerated approval timelines, ensured regulatory compliance, and supported the client's successful entry and expansion into the Saudi Arabian pharmaceutical market. FREYR's involvement strengthened the client's regulatory governance and operational efficiency.