The European Medicines Agency (EMA), through its Committee for Orphan Medicinal Products (COMP), oversees the designation of orphan drugs. Orphan Drug Designation (ODD) is a strategic business model for pharmaceutical companies to address the unmet needs in rare disease treatment, offering a pathway to compensate for revenue gaps due to patent expiries. The ODD allows for incentives such as protocol assistance, reduced fees, market exclusivity, and access to grants. Despite the incentives, companies face challenges including complex regulatory requirements and knowledge gaps. This whitepaper highlights Freyr's Global Labeling Xcellence (GLX) Framework is presented as a solution to streamline regulatory labeling processes, ensuring compliance and reducing overheads.
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