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Manufacturing and Supply Chain Assessment |
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AlvaMed's experts have many years of experience in medical device manufacturing and distribution for both large companies and start-ups. We can quickly assess the manufacturing readiness and pinpoint the potential issues for production scale-ups and transfers as well as identify and recommend fixes and improvements to existing production and supply chain operations. AlvaMed recently completed an in-depth evaluation of start-up's ability to rapidly increase production capacity. After assessing their GMP and quality systems, process controls, manufacturing systems, personnel capabilities and experience, vendor control and management, and technical support among other things, it was concluded that the time and investment required for the start up to meet the capacity needs was too great and a third party supplier should be utilized. | |
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