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    Pharma manufacturers should incorporate worst-case scenarios into assessment processes
    In a rapidly evolving regulatory landscape, leaders should remain ready to adapt to new legislation
    How pharma companies are solving regulatory challenges with AI-based technology
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    In part 2 of our series, leaders weigh in on what the pharma industry can expect in the coming year
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    It is never too early to consider CGMP requirements in pharma

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    A proactive approach to risk mitigation can help weed out quality issues before they become citations
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    Pharma quality regulation has evolved beyond routine CGMP compliance toward a more holistic, proactive approach
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    Optimal packaging and labeling solutions help ensure the delivery of safe, effective viral vector products
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    A new biomanufacturing era demands that suppliers and manufacturers partner to efficiently bring new therapies to market
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    CAPA remains an integral element of cost-effective quality management in pharma
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    CPV is required for regulatory compliance but can also provide process improvements
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    Deploying an automated process can help simplify safety and compliance information
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    Four strategic steps to creating and executing a hybrid audit protocol
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    First-in-class and orphan drugs dominated the agency's 2021 approvals
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    How the Bayview plant put itself — and pandemic preparedness — on a better course