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Featured Product In Regulatory Affairs

FDA’s Alternative Inspection Tools

FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions

$397.00
If you want to pass your next inspection, FDA’s Alternative Inspection Tools: Expert Answers to Drug and Biologics Manufacturers’ Questions is a must. Read More

Regulatory Affairs

International Standards for Clinical Trials

International Standards for Clinical Trials: Manual of ICH Efficacy Guidelines

$249.00
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FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference? – Webinar Recording/Transcript

$287.00
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Pharmaceutical Expedited Pathways – Webinar Recording/Transcript

$287.00
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Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success – Webinar Recording/Transcript

$287.00
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Manufacturing Quality: Using Audit Observations to Predict Problems – Webinar Recording/Transcript

$387.00
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Orphan Drug Designation

Orphan Drug Designation: Benefits and Challenges

$397.00
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Clinical Data Integrity

Clinical Data Integrity: FDA and DOJ Enforcement Priorities

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Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript

$287.00
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Building a World-Class Regulatory Intelligence and Support System – Webinar Recording/Transcript

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Engaging with the FDA: Best Practices for Dealing with Warning Letters, Seizures, Injunctions — and More – Webinar Recording/Transcript

$287.00
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MDUFA Reauthorization Developments: What Regulatory, Compliance and Quality Professionals Need to Know – Webinar Recording/Transcript

$287.00
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Jessica Greenbaum - 600Green

PDUFA and BsUFA Reauthorization Developments: What Regulatory, Compliance and Quality Professionals Need to Know – Webinar Recording/Transcript

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