Regulatory Affairs in the Pharmaceutical Industry is popular PDF and ePub book, written by Javed Ali in 2021-11-14, it is a fantastic choice for those who relish reading online the Medical genre. Let's immerse ourselves in this engaging Medical book by exploring the summary and details provided below. Remember, Regulatory Affairs in the Pharmaceutical Industry can be Read Online from any device for your convenience.
Regulatory Affairs in the Pharmaceutical Industry Book PDF Summary
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
Detail Book of Regulatory Affairs in the Pharmaceutical Industry PDF
- Author : Javed Ali
- Release : 14 November 2021
- Publisher : Academic Press
- ISBN : 9780128222232
- Genre : Medical
- Total Page : 287 pages
- Language : English
- PDF File Size : 16,6 Mb
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