2025 CPHI China

Booth Number: E12C25

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Compliance Secrets Top Drug Manufacturers Already Know

An insightful webinar designed for pharmaceutical manufacturers responsible for meeting FDA compliance requirements across registration, reporting, and fee-based programs. Whether you’re entering the U.S. for the first time or recalibrating your approach, this session delivers a strategic, structured overview of what’s expected—and how to get it right from the start. Topics covered: – Establishment registration

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Adapting to Change: Navigating FDA Regulatory Shifts and Evolving Tariff Policies in 2025

As global trade dynamics continue to shift, customs brokers, international suppliers to the U.S., and importers must stay ahead of critical regulatory and policy changes that directly impact compliance and operations. From the evolving enforcement priorities at the U.S. Food and Drug Administration (FDA) to renewed scrutiny of de minimis thresholds and tariff policy under

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Best Practices in Keeping Your Proprietary Information Secure When Filing with European Agencies

Discover the key requirements for Master Files (MFs) and Certificates of Suitability (CEPs) in European drug submissions—documents, fees, eCTD format, and how Registrar Corp simplifies compliance and protects your data.  

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Pharmapack 2025

Paris Expo, Porte de Versailles – Hall 7.2 | Paris, France

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Keep your Manufacturing Secrets Confidential

Discover the essentials of Master Files (MFs) in the drug industry with our experts, Melissa Sayers and Megan Moore. Learn about which agencies utilize MF submissions, what are the common required documents, when fees apply, and the submission processes. We’ll also cover electronic Common Technical Document (eCTD) submission, a common format for MFs, and how

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PCHI China

Booth Number: 1J53 Read more »
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