Insights On Regulatory Compliance

  1. 4 Conversations To Drive Your Business Case For Digital Validation 3/19/2025

    Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.

  2. Overcoming Challenges In Ophthalmic Formulations Through Polymer Selection 8/27/2025

    The growing demand for ophthalmic drugs is driven by aging populations and increased screen time, which contributes to rising eye conditions. Explore innovative solutions in ophthalmic drug development.

  3. Lessons Learned From Implementing FDA CSA Guidance 2/20/2024

    Explore how some drug manufacturers are using the latest Computer Software Assurance (CSA) guidance to reduce effort and cost and the bumps you may hit along the way.

  4. Building Excellence In Pharma Manufacturing Through Rigor 8/16/2025

    A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. Learn how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.

  5. How Bend Bioscience Standardized Operations And Boosted Compliance 8/8/2025

    Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

  6. The Shift To GMP-Compliant Automation In CGT Manufacturing 10/6/2025

    Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.

  7. How Process Intensification Supports A Sustainable Future 7/1/2025

    Discover how process intensification is revolutionizing bioprocessing by boosting efficiency and reducing waste. Hear from experts on how these innovations are driving a more sustainable future.

  8. A New Approach To Isolator Decontamination 4/8/2024

    How can you address the decontamination challenges associated with isolated fill-finish operations? New innovations are being implemented to ensure superior sporicidal reduction and operational safety.

  9. 2025 State Of Validation: Key Insights 5/14/2025

    Discover what’s driving change in validation in your industry in 2025 by exploring key Insights for a first look at this year’s top trends, challenges, and opportunities in validation.

  10. EU To U.S. Market: Understanding 3 Core Regulatory Contrasts 9/20/2024

    Learn about three key regulatory differences between the United States and the European Union that can significantly impact the success of your market entry.