Fundamentals of EU Pharmaceutical and Biologics Regulations PDF Download
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Author: Gloria Hall
Publisher:
ISBN: 9781947493124
Category :
Languages : en
Pages :
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Author: Gloria Hall
Publisher:
ISBN: 9781947493124
Category :
Languages : en
Pages :
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Author:
Publisher:
ISBN: 9780989802888
Category :
Languages : en
Pages :
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Compilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.
Author: Zeeshaan Arshad
Publisher:
ISBN: 9780997769739
Category : Biologicals
Languages : en
Pages : 252
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Author: Raps
Publisher:
ISBN: 9780982932100
Category : Biologicals
Languages : en
Pages : 372
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Author: Javed Ali
Publisher: Academic Press
ISBN: 0128222239
Category : Medical
Languages : en
Pages : 287
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Book 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
Author: Regulatory Affairs Professionals Society
Publisher:
ISBN: 9781947493865
Category :
Languages : en
Pages : 0
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Author: Gloria Hall
Publisher:
ISBN: 9781947493414
Category :
Languages : en
Pages :
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Author: Gloria Hall
Publisher:
ISBN: 9781947493216
Category :
Languages : en
Pages :
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Author: Gloria Hall
Publisher:
ISBN: 9781947493698
Category :
Languages : en
Pages :
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Author: Gloria Hall
Publisher:
ISBN: 9781947493438
Category :
Languages : en
Pages :
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