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MELBOURN TO ANNOUNCE SUCCESSFUL FDA AUDIT AND NEW SERVICES AT ICSE Melbourn Scientific MELBOURN TO ANNOUNCE SUCCESSFUL FDA AUDIT AND NEW SERVICES AT ICSE New services for tablet formulation, particle characterisation and nebuliser development will be announced by Melbourn Scientific, stand 8A54 at the ICSE exhibition in Madrid on 13 -15th October. The company has successfully passed an FDA audit despite being in the middle of a major expansion programme that is doubling its available lab space and creating dedicated new areas for its formulation team and other specialist services. Mark Hammond, CEO says that the FDA audit was very positive and this follows a successful UK MHRA GMP (Good Manufacturing Practices) inspection just a few weeks ago. Mark says, "one of the key drivers for us as a business is a policy of continuous improvement in all areas and this has been reflected by the successful completion of these two audits. "Our investment programme includes increasing capacity for our Accelerated Feasibility Studies. With the economic events of 2009 and the effects this has had on the pharmaceutical industry we have seen increased pressure on project timelines. As a result our clients need more information faster than ever before and we believe our AFS offer significant advantages. "Running a series of pre-formulation, analytical, stability and formulation studies in parallel offers an effective way of managing time critical projects. For example by using a matrix of tests to ensure that the key properties of a compound are well defined we can tailor an effective formulation to optimise delivery and stability of the final drug. Done well this process can add value to project by helping to inform design decisions and avoid expensive mistakes later in the process. "Demand for these types of study can be seen as an indication of product pipelines refilling. In addition, new delivery systems or dosage forms for existing drugs have also driven a need for specialist stability testing, all of which indicates rising levels of activity in the industry." More details about the new services will be announced at ICSE 2009
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