Insights On Regulatory Compliance

  1. TruBio Software: Performing A Single Pump Calibration 5/19/2025

    Confidently manage your bioprocessing systems with precision and ease by learning how to calibrate a single pump using innovative software, which ensures accurate fluid delivery.

  2. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  3. Integrated Approach In Managing CPV And APQR 11/12/2024

    Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

  4. Navigating The Evolution Of EU Health Technology Assessment (HTA) Regulation 5/9/2025

    The future of pharmaceutical access in Europe is being shaped by the new EU HTA regulation. Insights from Pharma 2025, featuring Herbert Altmann and Alexander Natz, shed light on this pivotal shift.

  5. Achieving Compliance With Confidence: The GxP Framework 7/28/2025

    Understand how to confidently meet GxP compliance in the life sciences. Explore a framework encompassing people, processes, products, and services for regulatory adherence and data integrity.

  6. EU GMP Annex 1 Compliance: Global Requirements And PIC/S Alignment 8/16/2025

    The 2023 revision of EU GMP Annex 1 resets the global standard for sterile manufacturing. Learn what’s changed and how PIC/S alignment extends these requirements to many non-EU markets.

  7. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

  8. Extractables And Leachables: Risk Management And Analytical Solutions 10/11/2023

    Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

  9. Application Of LC-UV/MS Workflows To Increase Efficiency 7/29/2025

    Discover how LC-UV/MS workflows help overcome analytical challenges in GLP-1 analog development to streamline impurity identification and boost lab efficiency in research.

  10. EMA Adopts Collaborative Approach With ATMP Guideline Update 7/17/2024

    The EMA has taken a collaborative approach with its updated ATMP guideline, aiming to streamline development and clarify regulatory expectations for cell and gene therapies across Europe's landscape.