Insights On Regulatory Compliance

  1. Resource Savings Through Effective Global Trade Compliance 5/16/2024

    Ensure consistent planning, accurate cost estimation, and enhanced delivery timelines for materials shipped across borders by partnering with a CDMO equipped with a dedicated trade compliance team.

  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. An Introduction To Laminar Airflow Technology In Aseptic Processing 8/21/2023

    Explore the vital role that laminar airflow technology plays in meeting sterile integrity standards and minimizing contamination risks in pharmaceutical cleanrooms.

  4. Key Considerations When Developing Your Combination Product 2/20/2024

    Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

  5. What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product 8/11/2023

    Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.

  6. Q&A Interview: Navigating The Launch Of ATMPs In Europe 5/29/2024

    Dive into this overview of the evolving regulatory landscape and better understand the importance of proactive planning, collaboration, and expert guidance in navigating the ATMPs ecosystem in Europe.

  7. Design–Build Cleanroom Projects: A Proven Risk Mitigating Methodology 11/17/2023

    Learn about the rising demand for cleanrooms in the biopharmaceutical industry, factors driving cleanroom design, building in flexibility, the role of critical path assessments, and more.

  8. Host Cell Impurities, Bioassays, Micro-Flow Imaging 4/9/2024

    Ensuring the safety and efficacy of cutting-edge biopharmaceuticals hinges on meticulous quality control measures. Explore the role of qPCR and MFI in safeguarding drugs from potential contamination.

  9. Regulatory And Quality Consulting, Operational Readiness Services 10/5/2023

    Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.

  10. Technology Transfer Strategies: Fill-Finish Automation And Robotics 10/30/2023

    Establishing early and clear tech transfer strategies is a key component of a holistic approach to drug development. Learn about the role that capable fill-finish solutions play in this process.