The challenge was to secure orphan drug designation and FDA approval while navigating complex federal and state regulations for a successful U.S. launch. This required strategic planning and multidisciplinary collaboration to address legal, scientific, and commercial issues, to plan for compliance and effective distribution. Orphalan sought our assistance in plotting its path forward and maintaining momentum in the competitive life sciences industry.
Shaping the future of rare disease treatment.
Our Pharmaceuticals and Biotechnology Regulatory team has been a closely involved partner in Orphalan's journey, developing a strategy to secure orphan drug designation for Cuvrior, navigating the FDA approval process, and achieving orphan drug exclusivity with approval. As Orphalan prepared for the U.S. launch, we addressed critical federal and state regulatory issues to ensure compliant marketing and distribution.
Our collaboration with Orphalan's senior executives involved a comprehensive approach, considering legal, scientific, medical, regulatory, and commercial factors crucial for success. By focusing on regulatory compliance and strategic planning, we helped Orphalan move efficiently to market entry, reinforcing their position in the life sciences industry.
With our ongoing support, Orphalan continues to thrive and deliver impactful treatments to patients with this rare condition.
