Regulatory Affairs in the Pharmaceutical Industry
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. - Updated reference on drug approval processes in key global markets - Provides comprehensive coverage of concepts and regulatory affairs - Presents a concise compilation of the regulatory requirements of different countries - Introduces the fundamentals of manufacturing controls and their regulatory importance Key topics: Review: A comprehensive reference on regulatory affairs in the global Pharmaceutical Industry. From the Back Cover: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference compiling all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the contents cover new drug, generic drug and their development, regulatory filings in different countries, different phases of clinical trials and submitting regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). The book will also impart the knowledge about the manufacturing controls and
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