Fundamentals of US Regulatory Affairs PDF Download
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Author:
Publisher:
ISBN:
Category : Biologicals
Languages : en
Pages : 540
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Book Description
Author:
Publisher:
ISBN:
Category : Biologicals
Languages : en
Pages : 540
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Book Description
Author: Peggy Berry
Publisher:
ISBN: 9780978700621
Category : Pharmaceutical policy
Languages : en
Pages : 464
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Book Description
Author: Alix E. Alderman
Publisher:
ISBN: 9780982932063
Category : Biologicals
Languages : en
Pages : 552
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493636
Category :
Languages : en
Pages :
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Book Description
Author: Regulatory Affairs Professionals Society
Publisher:
ISBN:
Category : Biologicals
Languages : en
Pages : 270
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Book Description
Author: Pamela Anne Jones
Publisher:
ISBN: 9781947493179
Category :
Languages : en
Pages : 502
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Book Description
Author: Douglas J. Pisano
Publisher: CRC Press
ISBN: 1040061974
Category : Medical
Languages : en
Pages : 466
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Book Description
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
Author: Regulatory Affairs Professionals Society
Publisher:
ISBN:
Category : Biologicals
Languages : en
Pages : 93
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Book Description
Author: Salma Michor
Publisher:
ISBN: 9780989802802
Category :
Languages : en
Pages :
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Book Description
Reference book of laws, standards and regulations applicable to healthcare product manufacture on the international market.
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
