3 Review(s)

Unlock the secrets of the pharmaceutical regulatory landscape with the comprehensive 'Textbook of Regulatory Affairs.' This indispensable guide takes you on a journey through the intricacies of documentation, product approval, and post-marketing surveillance in the dynamic pharmaceutical industry. Delve into the first section, where you'll unravel the mysteries of documentation with topics ranging from Master Formula Records to Drug Master Files. Explore the nuances of generic drug product development, the Hatch-Waxman Act, and the Code of Federal Regulations (CFR). Move on to the second section, navigating through drug product performance assessments, ANDA and NDA approval processes, in-vitro and in-vivo studies, and post-marketing surveillance. The third section sheds light on the regulatory requirements for product approval, covering APIs, biologics, and novel therapies. Gain insights into the complex world of CMC (Chemistry, Manufacturing, and Control) and post-approval regulatory affairs. Navigate through CTD and ECTD formats, ICH guidelines, and the regulatory landscapes of EU, MHRA, TGA, and ROW countries. Sections four, five, and six unfold the realms of CMC, post-approval regulatory affairs, non-clinical drug development, and clinical trials. Learn about global submission processes, investigation of medicinal product dossiers, formulation procedures, and the critical aspects of clinical trial protocols and safety monitoring.