Category: Drugs

Health Canada Master Files (MFs) are a powerful tool for protecting proprietary information while streamlining regulatory submissions — but navigating their requirements can be complex. Understanding how to prepare, submit, and maintain a compliant Master File is essential to safeguard intellectual property, avoid costly delays, and accelerate product approvals in Canada’s competitive pharmaceutical product market.

FDA inspections are inevitable for drug manufacturers — whether to secure pre-approval for a new product, ensure GMP compliance, follow up on post-market reports, or investigate complaints and recalls. While the reason may differ, FDA investigators follow established procedures, and knowing what to expect can make the difference between a smooth inspection and a disruptive

The Generic Drug User Fee Amendments (GDUFA) are central to FDA oversight of generic drug manufacturers, but navigating the requirements isn’t always straightforward. Self-identification, program fees, and DMF submissions create recurring challenges that can be costly if misunderstood or overlooked.     In this session, Melissa Sayers, Drug Regulatory Manager, will simplify the complexities of GDUFA

Drug registration and listing renewals are non-negotiable for maintaining FDA compliance—and missing even one step can result in product inactivation or regulatory action. This webinar is designed for manufacturers, private labelers, and compliance professionals who need clear, actionable guidance on staying ahead of FDA requirements. Our experts will break down what’s required, what’s commonly missed,

Join us for this informative webinar designed for China-based pharmaceutical and API manufacturers preparing Master File (MF) submissions to global regulatory agencies, including the U.S. FDA, Health Canada, EMA, and others. This session will provide essential insights into the MF lifecycle and help ensure your submissions are secure, complete, and compliant.  Topics include:  Types of

Booth Number: 113

Booth Number: Pending  

Booth Number: E12C25

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

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

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.  

Since 2020, FDA has imposed more requirements on the drug industry. Besides establishment registrations and product listing that have been required for decades, fees are now collected by the FDA on more manufacturers on an annual basis. Amounts of listed drug products are now required to be reported on an annual basis. Stay out of

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

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