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 Master Files and their regulatory purpose 

• Required documents for submission across various agencies 

• eCTD formatting standards and electronic submission pathways 

• Agency-specific requirements, including when an authorized party is needed 

• Global fee structures, including FDA GDUFA and Health Canada user fees 

• How to keep Master Files active through updates and reporting 

• Best practices for maintaining confidentiality and protecting sensitive data 

• How Registrar Corp supports secure and compliant submissions as a U.S. Agent 

Live Q&A:
Engage directly with regulatory experts and get answers to your specific submission challenges.