Quality & compliance

  • Parexel on the pulse2:08

    Parexel on the pulse

    Parexel regulatory expert, Mark Birse, gives an update on BREXIT.

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  • Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Once the full fury of the pandemic was understood, the Food and Drug Administration turned to a number of tools that already existed to help fill the gap for information that was normally...

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  • Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    In the Federal Register notice, FDA reiterated that drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients.

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  • The long and winding road for quality metrics takes another turn

    The long and winding road for quality metrics takes another turn

    In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

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  • Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

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  • Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

    Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

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  • How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

    How Fair is FDA in Enforcement? Stacking Up the Agency Against a New Memo from the White House

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  • Five points to remember if FDA issues a Form 483

    Five points to remember if FDA issues a Form 483

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  • Case Study Achieving Product Endorsement after a FDA Warning Letter

    Case Study Achieving Product Endorsement after a FDA Warning Letter

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  • Compliance Consulting Services Brochure for Law Firms

    Compliance Consulting Services Brochure for Law Firms

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  • I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    On August 19, FDA published the final guidance Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. You can find...

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  • An overview of the recent Executive Order on Critical Drugs Made in America

    An overview of the recent Executive Order on Critical Drugs Made in America

    On August 6, 2020 the president of the United States signed an Executive Order (EO) on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. The...

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  • How to interact virtually with health authorities

    How to interact virtually with health authorities

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  • GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...

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  • Will the FDA “CARE” More About Your Supply Chain?

    Will the FDA “CARE” More About Your Supply Chain?

    On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic (a copy of the public law...

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  • Has EMA started a domino effect for more regulation of API manufacturing?

    Has EMA started a domino effect for more regulation of API manufacturing?

    On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. You can find a...

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  • What’s Around the Corner for FDA Inspections?

    What’s Around the Corner for FDA Inspections?

    There have been two recent activities from the U.S. Food and Drug Administration (FDA) that provide industry more insight into how the agency is approaching product and manufacturing quality...

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  • Risk Mitigation and Compliance Consulting Brochure for BioPharma Companies

    Risk Mitigation and Compliance Consulting Brochure for BioPharma Companies

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