QUOTIENT SCIENCES LIMITED offer service "Orphan Drug Development"

Support for accelerating orphan drug development from candidate selection through commercial manufacture and supply. With more than 300 million people worldwide living with identified rare diseases, developing treatments for these unmet needs is a major pharmaceutical industry priority, though drug developers still face challenges including limited R&D budgets, an evolving regulatory framework, and difficult product development and clinical recruitment despite improved regulatory support and commercial incentives for orphan drugs. Capabilities include pre-formulation and API characterization, formulation and process development, first-in-human testing and acceleration to proof of concept, bespoke clinical manufacturing and supply (Phase I-III) for patient trials, and rapid scale-up and commercial manufacturing of low-volume products.