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This course is designed to impart the fundamental knowledge on the drug development process, regulatory requirements for approval of new drugs, drug products and cosmetics in regulated and semi-regulated countries. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products and cosmetics in regulated and semi-regulated countries.

This Textbook is designed to impart the fundamental knowledge on the medical devices and in vitro diagnostics, basis of classification and product life cycle of medical devices, regulatory requirements for approval of medical devices in regulated countries like USFDA, EMA and ASAIN countries along with WHO regulations. It prepares the students to learn in detail on the harmonization initiatives, quality and ethical considerations, regulatory and documentation requirements for marketing medical devices and IVDs in regulated country and global level.