Articles

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  • GDUFA, Take II

    GDUFA’s second iteration emerges from backlogs and negotiations, promising speed, clarity and transparency

    Karen Langhauser, Chief Content Director
    12/12/2016
  • 5 Strategies for Generic Supply Chains

    What leading companies are doing to drive holistic improvements across their complex supply chains

    Andrew Gonce, Xin Huang, Jordan Levine and Martin Lösch, McKinsey & Company
    12/12/2016
  • The Digital Game-Changer

    For pharma operations, the question isn’t “When to go digital?” It’s “How fast can we get there?”

    Dr. Marcus Ehrhardt, Partner, PWC’S STRATEGY&
    12/09/2016
  • The Rise of Biosimilars

    North America and Europe will dominate the global biosimilars market as demand rises for these products

    Nigel Walker, Managing Director, That’s Nice / Nice Insight
    12/09/2016
  • Validation & Qualification in Pharma Facilities

    Validation, calibration and qualification are extremely critical in pharmaceutical processes. Understanding them is necessary in order to meet cGMP guidelines.

    Edward Simpson, Calibration and Technical Engineer, RS Calibration
    12/07/2016
  • Pros and Cons of Biosimilars

    There are a number of points of view and opinions on how good or necessary biosimilars actually are

    Emil W. Ciurczak, Contributing Editor
    12/07/2016
  • The Changing Biopharma Risk Equation

    Multinational survey of pharma execs offers insight on pharmaceutical companies’ growth strategies and risk management in the challenging biologics landscape

    Andrew Bulpin, vice president, Process Solutions, Merck KGaA
    11/12/2016
  • GMP in Cleanroom Maintenance: Myths and Facts

    Every cleanroom requires a carefully controlled environment maintained with Good Manufacturing Practices to prevent contamination

    Omar Lopez, MBA, Pristine Environments Inc.
    11/12/2016
  • 4 Steps for Managing Biopharmaceutical Projects

    In order for biopharma companies to move quickly and adaptively enough, an outstanding project management process is critical

    Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant, and Julie Spyrison Associate Director, Regulatory Operations at BioTechLogic, Inc.
    11/11/2016
  • No-Compromise APIs

    Hyderabad-based API provider Neuland Labs sheds the stigma of Indian manufacturers by building stringent quality control into every process

    Karen Langhauser, Chief Content Director
    11/08/2016
  • Financial Justification in Pharma

    Selection of any pharma manufacturing process, including supply chain and quality assurance practices, requires financial justification

    Girish Malhotra, PE, President, EPCOT International
    11/04/2016
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