Ensuring Quality and Compliance: Foundational Principles for Drug Development
Ensuring quality and compliance in drug development is no easy task with complex regulations on both sides of the Atlantic.
In this whitepaper, Helen Kargaryani, Global Head of Quality at NDA outlines foundational principles for regulatory compliance, emphasizing Quality Management Systems and Good Manufacturing Practices. She discusses risk management throughout the product life cycle and the similarities/differences between the US and European guidelines.
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