The development of medical device combination product convenience packages continues to throw up interesting technical/regulatory challenges. Inclusion of pre-sterilized syringes and other applicators as part of these products...
Read MoreSo you may be a start-up or virtual life sciences company, but you still have a requirement to have a Quality System to develop your pharmaceutical/life sciences products. That’s true if you are a company that is regulated by...
Read MoreA significant driver in the improvement in bioprocess plants profitability relates to the reduction in non-value added lead times.
Read MoreSome would argue that there is a conflict between the idea of lean practices and a highly regulated quality compliant environment. However, upon closer analysis this is not necessarily the case. Both Lean and Compliance have...
Read MoreCritical materials and suppliers are selected early in development. By the time Technology Transfer occurs for commercialization, it is often too late to make changes to these critical components without having to do additional...
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Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.