MIA approval positions Melbourn well for Inhalation Asia 26-28th June 2013
Import testing for companies wanting to access European markets is just one of the services being offered by Melbourn Scientific at Inhalation Asia.
Melbourn Scientific has over 20 years of experience in analytical testing and formulation for inhaled products and now boasts one of largest teams in Europe offering contract research for OINDP development, product development and associated CMC services. These include formulation development, analysis, stability studies, inhaler testing and small scale manufacture of clinical trials materials.
Melbourn Scientific has been audited by the MRHA and FDA and was recently awarded a Manufacturer’s/Importer’s Authorisation (MIA) allowing it to be named as an EU testing and release site.
CEO Mark Hammond says the new licence is a good endorsement of the quality of the company’s cGMP procedures and extends its capabilities. He says; “The EU is an important market and with the Manufacturer’s / Importer’s Authorisation (MIA), we are able to import commercial products which 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.”
Melbourn Scientific continues to make significant investment in all areas for pulmonary, and intra-nasal product and device development.
Following the introduction of the Proveris SprayVIEW system and Vereo actuator, it became the first CRO in Europe to offer the cGMP spray pattern and plume geometry measurements required for nasal spray and MDI approval for the US market.
Its expertise in dry powder analysis services, which includes novel technologies like the Freeman Technology FT4 Powder Rheometer which characterises powders in order to predict performance, is proving particularly popular with device developers.
The FT4 quantifies dynamic properties (flow energy, stability, aeration) bulk properties (permeability, compressibility) and shear properties. This improves quality control and optimisation of the formulation from development through to manufacture.
In response to demand for its GMP nasal spray testing services, Melbourn Scientific has a dedicated laboratory for the analysis of droplet size, particle characterisation, spray pattern, plume geometry, and device performance testing with equipment that includes the Malvern Spraytec and a range of impactor testing.
Hammond continues ‘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.’