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Chandra Mohan

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EU Variations-Chandra.pptx
Introduction to the ICH Guidelines
Drug Regulatory Systems in India
Comparison of Drug Approval Process in United States & Europe
EU POST-APPROVAL CHANGES
EU REGULATORY SUBMISSIONS
US FDA post approval changes
US FDA Regulatory Submissions
ICH eCTD specification
CTD structure
Introduction to the regulatory affairs
ICH Q6A Specifications by Chandra Mohan
Regulatory Affairs by Chandra Mohan