Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Author: Gloria Hall
Publisher:
Published: 2020-03-06
Total Pages:
ISBN-13: 9781947493414
DOWNLOAD EBOOK →Author: Gloria Hall
Publisher:
Published: 2020-03-06
Total Pages:
ISBN-13: 9781947493414
DOWNLOAD EBOOK →Author:
Publisher:
Published: 2014-05-23
Total Pages:
ISBN-13: 9780989802864
DOWNLOAD EBOOK →Compilation of the pharmaceutical and biologics chapters from Fundamentals of US Regulatory Affairs Eighth Edition and Fundamentals of International Regulatory Affairs Second Edition,
Author:
Publisher:
Published: 2014-05-23
Total Pages:
ISBN-13: 9780989802888
DOWNLOAD EBOOK →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:
Published: 2017
Total Pages: 252
ISBN-13: 9780997769739
DOWNLOAD EBOOK →Author: Regulatory Affairs Professionals Society
Publisher:
Published: 2023-05
Total Pages: 0
ISBN-13: 9781947493865
DOWNLOAD EBOOK →Author: Sandy Weinberg
Publisher: John Wiley & Sons
Published: 2011-04-18
Total Pages: 295
ISBN-13: 111800227X
DOWNLOAD EBOOK →This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.
Author: Javed Ali
Publisher: Academic Press
Published: 2021-11-14
Total Pages: 287
ISBN-13: 0128222239
DOWNLOAD EBOOK →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: Gloria Hall
Publisher:
Published: 2018-09-04
Total Pages:
ISBN-13: 9781947493216
DOWNLOAD EBOOK →Author: Mindy J. Allport-Settle
Publisher: PharmaLogika Books
Published: 2018-02-20
Total Pages: 688
ISBN-13: 9781937258177
DOWNLOAD EBOOK →FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR§11) and Guidance for Industry - Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community (21CFR§26) - Part 200 Drugs: General (21CFR§200) - Part 207 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and The National Drug Code (21CFR§207) - Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General (21CFR§210) - Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (21CFR§211) - Part 600 Biological Products: General (21CFR§600) - Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices (21CFR§807) - Part 820 Quality System Regulation (21CFR§820) - Part 11, Electronic Records; Electronic Signatures - Scope and Application - Guidance for Industry and FD A Staff: Current Good Manufacturing Practice Requirements for Combination Products - Guidance for Industry: CGMP for Phase 1 Investigational Drugs - Process Validation: General Principles and Practices - PAT - A Frame work for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance - Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations - Contract Manufacturing Arrangements for Drugs: Quality Agreements - Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP - Formal Dispute Resolution: Sponsor Appeals Above the Division Level Reference Tools: - Glossaries combined in one location - GMP Keyword Index for 21CFR211 - Combined Index for all documents