The Pharmaceutical Regulatory Process (Paperback, 2nd edition)

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

General

Imprint:	Crc Press
Country of origin:	United Kingdom
Series:	Drugs and the Pharmaceutical Sciences
Release date:	June 2019
First published:	2008
Editors:	Ira R. Berry • Robert P. Martin
Dimensions:	229 x 152mm (L x W)
Format:	Paperback
Pages:	650
Edition:	2nd edition
ISBN-13:	978-1-138-38128-5
Categories:	Books > Science & Mathematics > Biology, life sciences > General Books > Professional & Technical > Technology: general issues > Engineering: general Books > Professional & Technical > Environmental engineering & technology > General Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Pharmaceutical industries Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Promotions
LSN:	1-138-38128-4
Barcode:	9781138381285

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