With the growing market focus on rare diseases, we support companies who are developing Orphan Drugs. HiTech Health has the experience and expertise to help with all operational aspects, from the development of orphan drugs to the manufacture and launch of these products. Activities include:
Orphan drug designation processes for applications to the European Medicine Agency (EMA) and the Food and Drug Administration (FDA).
Strategic advice and support at each stage of Product development, Technical Transfer, Validation, manufacturing, launch and supply. This includes products given accelerated approval timelines.
Supplier selection, audits and commercial contracts.
Qualified Person (QP) and Responsible Person (RP) services including Compliance expert advice and oversight.
Focused supply chain management for market access and efficient product delivery (including cold chain product supply).