Insights On Regulatory Compliance

  1. 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.

  2. Measuring And Monitoring Environmental Surface Residues 4/1/2025

    Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.

  3. What Is Aseptic Processing? 1/9/2026

    Aseptic processing sterilizes products and packaging separately, then combines them in a sterile environment. See how this method ensures safety, extends shelf life, and protects medicines from contamination.

  4. FDA Product Recalls: A Wake-Up Call For Life Sciences Manufacturers 10/9/2024

    Discover why manufacturers must adopt more consumer-centric recall strategies to maintain trust and safeguard their market position.

  5. Three Key Strategies To Guide Efficient And Effective Recall Management 2/18/2025

    Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

  6. Aggregation In Antibody-Drug Conjugates: Causes And Mitigation 9/1/2025

    Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.

  7. Environmental Monitoring Vs. Good Aseptic Technique 4/23/2024

    Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.

  8. Aseptic Expertise And Delivery Of Services 8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

  9. Mold In Cleanrooms: A Persistent Threat And The Case For Proactive Bio-Decontamination 11/17/2025

    Learn how a comprehensive investigation and systems-level bio-decontamination strategy successfully eliminated persistent mold contamination in a vaccine manufacturing facility's high-risk area.

  10. Characterization And Impurity Profiling Of Combined Amylin And GLP-1 Analogs 7/29/2025

    GLP-1 receptor agonists are transforming diabetes and weight loss treatment. Discover how to enable precise impurity analysis and characterization of complex, fatty acid-modified peptide therapeutics.