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Quality is often defined in manufacturing as a measure of excellence or a state of being free from defects. Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed. Discover key ingredients to robust and advanced quality planning that are essential to quality in contract manufacturing.
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Biologics and other targeted therapy techniques are creating opportunities for innovative device solutions that meet the needs of specific patient groups. As these therapies often require low annual volumes, the associated device manufacturing strategy must also fit commercial expectations, even at those volumes.
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It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
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Pharmaceutical companies are facing increasing pressure to accelerate development timelines and bring more targeted therapies to market, all while handling increased regulatory hurdles. Industry experts discuss how to ensure success and speed-to-market with drug delivery projects by establishing a firm foundation when working with a CMO.
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As demand for capabilities and resources grows throughout a project, both become strained in-house and the scale-up process becomes a steeper hill to climb. Potential CMO partners should be able to help a medtech understand the implications of its outsourcing needs, relevant to the company’s inputs and methods.
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