Zelthy-Compassionate Access Reviews & Product Details

What is this product? Zelthy Compassionate Access is an application for pharmaceutical companies managing expanded access (compassionate use) programs. It handles the complete program workflow: patient request intake, physician and medical review, ethics committee approval, regulatory filing (FDA, TGA, EMA), and logistics coordination for drug supply — replacing the manual, multi-step approval process that often delays patient access to investigational therapies. Key Features & Functionalities - Patient request intake with physician documentation - Medical review and clinical assessment workflows - Ethics committee approval management - Regulatory filing for FDA, TGA, EMA, and other authorities - Drug supply logistics coordination - Program analytics and reporting Primary Solution & Value Expanded access programs involve a complex multi-step approval chain — medical review, ethics approval, regulatory filing — that can delay patient access to investigational therapies by weeks. This application digitizes the full approval workflow, reducing cycle time while maintaining the documentation required for regulatory compliance.