Melbourn Scientific has been awarded a Manufacturer's/Importer’s Authorization (MIA) and will be named as the EU testing and release site for an aseptically prepared medicinal product on a client’s pending Marketing Authorization Application.
Carol Barbour, quality director at MS, said, “The new license is a good endorsement of the quality of Melbourn’s procedures and will extend its capabilities. With the MIA, we will be able to import commercial products that have been manufactured outside the EU and to test them prior to release for sale within the EU/EEA. This extends the scope of our services to cover more of the product lifecycle and will be valued by clients who want to outsource these critical activities. Also with our stability storage capabilities, we are able to provide this service if the client requires on-going stability to be performed in the EU.”
Melbourn Scientific offers contract research including formulation development, analysis, stability studies and small scale manufacture of clinical trials materials.