As bio/pharmaceutical companies navigate the capacity and supply chain challenges presented by the COVID-19 pandemic, attention also needs to be focused on emerging and established quality and regulatory challenges.
In this Regulatory Sourcebook, the editors share the latest insight and analysis for regulatory and industry trends, supply chain issues, and quality best practices including the following:
• Innovation and FDA’s Focus Areas of Regulatory Science report
• Serialization
• Counterfeit COVID-19 vaccines
• CMC strategies
• Data integrity
• Intellectual property