Manufacturers
Manage reliable and secure supply chain
Maintain risk mitigated, reliable, and efficient manufacturing
operations
Provide safe, efficacious, and defect-free high quality drug
products
Regulators
Stand in for the consumer (patient) to ensure quality
Exercise risk-commensurate regulatory oversight
Continue at: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM456367.pdf
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