Insights On Regulatory Compliance

  1. Laying Supply Chain Foundations That Bring Confidence To Compliance 9/21/2025

    Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

  2. Robotics And Automation Addressing Production Shortages For Compounding Pharmacies 9/11/2024

    Drug shortages have increased the burden on compounding pharmacies. Robotics and automation can streamline processes, improve accuracy, and ensure quality to address challenges faced by these facilities.

  3. Richter BioLogics Drives Efficiency And Compliance With Unified Quality 1/21/2026

    Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.

  4. Winning Strategies For Oral Dosage Form Development And Manufacturing 10/7/2024

    Failure to identify a compound’s red flags early in development often manifests as program delays or failures. Discover how to avoid these setbacks through complete molecular characterization.

  5. Why Compounding Pharma Manufacturers Should Evaluate BFS Systems 12/5/2024

    Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.

  6. Advancing Drug Safety And Improving R&D Productivity With The Liver-Chip S1 12/10/2024

    Explore how the Emulate Liver-Chip S1 revolutionizes predictive toxicology by mimicking human liver biology, achieving superior sensitivity and specificity.

  7. 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.

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    Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

  9. Controlling Comment Chaos: A Medical Writing Leader's Story 7/14/2025

    Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.

  10. Selecting The Best Deterministic Method For Your CCIT Project 3/31/2025

    Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.