It is imperative, therefore, that companies plan early and plan well to mitigate such risks and increase their chances of success, says Rob Scott (pictured), Head of Translation Consultancy at eXmoor Pharma.
Variables can range from operating within a regulatory space that may not fit the product or modality being developed, the complexity of the manufacturing process or the ability to meet demand.
One such variable that requires upfront investment is the provision of materials to be used in the manufacturing process.
Materials are a fundamental component of the manufacture and supply of any medicinal product and, as such, warrant key consideration as part of any CMC strategy.
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