Fundamentals of US Regulatory Affairs
Author :
Publisher :
Page : 740 pages
File Size : 19,43 MB
Release : 2019
Category : Biologicals
ISBN : 9781947493339
Author :
Publisher :
Page : 740 pages
File Size : 19,43 MB
Release : 2019
Category : Biologicals
ISBN : 9781947493339
Author : Peggy Berry
Publisher :
Page : 464 pages
File Size : 19,37 MB
Release : 2009-08
Category : Pharmaceutical policy
ISBN : 9780978700621
Author : Alix E. Alderman
Publisher :
Page : 552 pages
File Size : 15,57 MB
Release : 2013-06-30
Category : Biologicals
ISBN : 9780982932063
Author :
Publisher :
Page : 540 pages
File Size : 34,15 MB
Release : 2013
Category : Biologicals
ISBN :
Author : Syed Rizwanuddin Ahmad
Publisher :
Page : pages
File Size : 48,4 MB
Release : 2017-07
Category :
ISBN : 9780997769777
Author : Javed Ali
Publisher : Academic Press
Page : 287 pages
File Size : 28,22 MB
Release : 2021-11-14
Category : Medical
ISBN : 0128222239
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 : Douglas J. Pisano
Publisher : CRC Press
Page : 466 pages
File Size : 31,77 MB
Release : 2008-08-11
Category : Medical
ISBN : 1040061974
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 : Stephen F. Amato
Publisher : Elsevier
Page : 203 pages
File Size : 25,40 MB
Release : 2014-10-27
Category : Technology & Engineering
ISBN : 0857099205
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. - Addresses global regulations and regulatory issues surrounding biomaterials and medical devices - Especially useful for smaller companies who may not employ a full time vigilance professional - Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Author : Mujadala Abdul-Majid
Publisher :
Page : 1064 pages
File Size : 34,34 MB
Release : 2015-07
Category : Biologicals
ISBN : 9780967311586
Reference book of regulations and laws covering healthcare product manufacture and marketing in the US.
Author : Gloria Hall
Publisher :
Page : pages
File Size : 31,47 MB
Release : 2021-06-25
Category :
ISBN : 9781947493636