Insights On Regulatory Compliance

  1. Key Considerations For A Successful EU Orphan Drug Launch
    7/22/2019

    During this interactive webinar, the speakers involved will utilize their experience to guide you through the EU product launch process, from submitting your Marketing Application (MA) to final distribution of drug product to the end-user.

  2. Avoiding HPAPI Contamination
    3/20/2019

    Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies. 

  3. Container Closure Integrity Testing Method Development
    1/2/2019

    Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

  4. New Guidelines For Container Closure Integrity Testing
    12/20/2018

    Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.

  5. Using A CMO To Streamline Process Characterization
    3/19/2019

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

  6. Container Closure, Pharmaceutical Glass And Plastic Testing
    12/28/2018

    This presentation features testing overviews for container closures, pharmaceutical glass and plastic and covers common tests and techniques for each.

  7. Looking Under The Hood Of The Unified Lab
    11/22/2017

    Striving to bring the way we acquire, share and gain insights from scientific data, through a community and the framework for standardization and linked data.

  8. Advances In Flowmeter Technology
    3/19/2019

    This article disucsses two trends turning the flowmeter industry on its ear: advances in flowmeter diagnostics and the adoption of smartphone-like technology to improve access and communications.

  9. Why Invest In Emerging Markets Now
    10/10/2018

    Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

  10. Complimentary Workshop: EU Product Launch - Key Timeline Milestones From PhIII To Launch
    7/17/2019

    Launching a product into Europe but unsure about the different requirements for a European market? Join our experts in September at our EU Product Launch Workshop series: Key timeline milestones from phase 3 to launch, where they will guide you through an EU product launch.