PHARMACEUTICAL CASE STUDIES
Controlling costs in pharmaceutical drug development A global pharmaceutical company wanted to benefit from globalisation and from the effectiveness of their separate country operations which had disparate operating, regulatory and market requirements. Resultant benefits included cost reduction and quality improvements at corporate regional and local levels. Performance improvement was demonstrated by measurement against agreed clinical trial milestone targets. Read more
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Technology Transfer A pharmaceutical company producing asthma medicines had been subject to product recalls and negative regulatory audits. One of the main areas of concern was the technology transfer process between product development and manufacturing. Working on a variety of formulations including metered dose aerosols, solid dosage forms and small volume sterile liquids we developed a sustainable technology transfer process which ensured that the transfer mechanism between the development and operations functions was robust, fully documented and compliant with international regulatory guidelines. Outcomes included successful regulatory audits and better team working across the departments responsible for bringing products to market. This enabled product launches to be delivered to time and cost targets. |
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