Melbourn Scientific has been audited by the MRHA and FDA and was recently awarded a Manufacturer's/Importer’s Authorization (MIA) allowing it to be named as a testing and release site in the EU.
Mark Hammond, Melbourn’s chief executive officer, said, “The new license is a good endorsement of the quality of the company’s cGMP procedures and extends its capabilities. The EU is an important market and with the MIA, we are 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 has extended our portfolio of services for international clients.”
Mr. Hammond added, “We are seeing an increase in interest from companies across Asia and India who are looking for CRO partners with proven expertise in supporting inhaled and intranasal programs. Inhalation Asia will be the first time we have exhibited in the Far East and we are looking forward to the experience.”
Melbourn Scientific provides services for all areas of pulmonary, and intra-nasal product and device development. Its expertise in dry powder analysis services includes the Freeman Technology FT4 Powder Rheometer, which characterizes powders in order to predict performance. The company has a dedicated lab for the analysis of droplet size, particle characterization, spray pattern, plume geometry, and device performance testing with equipment that includes the Malvern Spraytec and a range of impactor testing.
Melbourn Scientific Gains MIA in EU
Published March 21, 2013
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