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£131.79

Academic Press Regulatory Affairs in the Pharmaceutical Industry

Name: Regulatory Affairs in the Pharmaceutical Industry
Brand: Academic Press
Price: 131.79 GBP
Availability: InStock

Quality Assurance & Total Quality Management

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Description

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 Features

Regulatory Affairs in the Pharmaceutical Industry

Product type: ABIS BOOK

Brand: Academic Press

Product Specifications

Brand: Academic Press
Format: paperback
ASIN: 0128222115
Category: Books > Subjects > Business, Finance & Law > Management > Quality Assurance & Total Quality Management
Domain: Amazon UK
Release Date: 19 November 2021
Listed Since: 18 December 2019

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Academic Press Regulatory Affairs in the Pharmaceutical Industry

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