Insights On Regulatory Compliance

  1. Nitrosamine Testing For Regulatory Readiness 7/8/2025

    Discover how delivering ultra-sensitive detection of nitrosamine impurities like NDMA and NDEA helps safeguard pharmaceutical quality and meet evolving global regulatory demands.

  2. How Intuitive Decision Rules In Clinical Trials Can Support Regulatory Requirements 6/12/2024

    See how Bayesian decision rules in clinical trials can align with regulatory standards, offering intuitive and adaptive solutions amidst traditional challenges in frequentist frameworks.

  3. From Crisis To Confidence: Ensuring Smooth Regulatory Submissions 10/8/2024

    Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.

  4. Continued Process Verification: Driving Consistent Quality In Manufacturing 12/9/2024

    Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

  5. Integrated Strategies for Achieving Regulatory Milestones Faster 10/12/2023

    Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

  6. The Bumpy Road Ahead: Stakeholder Perspectives On EU HTAR 1/17/2025

    Experts convened at ISPOR Europe 2024 to discuss the upcoming EU Health Technology Assessment Regulation (EU HTAR), sharing insights and lessons learned from recent national reforms.

  7. Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap 7/23/2025

    As biopharma complexity grows, flexible CDMOs like Afton Scientific are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

  8. Preparing Documents For Transparency And Disclosure Requirements 3/14/2025

    Learn how transparency and disclosure ensure that clinical data is accessible to the public and regulatory bodies in medical writing, which helps foster trust and accountability in the scientific community.

  9. A State-Of-The-Art Syringe Liquid Sampler 6/24/2025

    Discover a cutting-edge syringe liquid sampler for Life Sciences that offers USP <788> compliance, versatile syringe compatibility, and advanced features for precise particulate testing.

  10. Introducing Laminar Airflow Technology In Aseptic Processing 8/21/2023

    The global market for injectable drugs will reach $69.13 billion by 2028. Examine the vital role of laminar airflow technology in meeting sterile integrity standards and minimizing contamination risks.