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The Pharmaceutical Regulatory Process

List Price: $87.99
SKU:
9781138381285
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  • Product Details

    Author:
    Ira R. Berry, Robert P. Martin
    Format:
    Paperback
    Pages:
    492
    Publisher:
    CRC Press (June 7, 2019)
    Language:
    English
    Audience:
    Professional and scholarly
    ISBN-13:
    9781138381285
    Weight:
    32.125oz
    Dimensions:
    6" x 9"
    File:
    TAYLORFRANCIS-TayFran_260403050835162-20260403.xml
    Folder:
    TAYLORFRANCIS
    List Price:
    $87.99
    Country of Origin:
    United States
    Series:
    Drugs and the Pharmaceutical Sciences
    Case Pack:
    1
    As low as:
    $83.59
    Publisher Identifier:
    P-CRC
    Discount Code:
    H
    Pub Discount:
    30
    Imprint:
    CRC Press
  • Overview

    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.