Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Challenges With Hallucinogens, Psychedelics, And Entactogens 5/9/2025

    This eBook examines the complex regulatory landscape and the preclinical, clinical, and manufacturing challenges involved in developing Schedule 1 therapeutics.

  2. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  3. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

  4. Biofluorescent Particle Counters Are Gaining Momentum 4/28/2025

    The 2025 BioPhorum report highlights challenges and trends in drug filling operations and how they are advancing towards biofluorescent particle counters. Discover an approach that aligns with industry needs.

  5. CDMO Uses Robotic Gloveless Isolator For Advanced Therapeutics 4/28/2025

    CDMOs must innovate production architectures to meet the demands of advanced therapeutics to ensure a reliable supply and compliance. Discover how these approaches advance modern medicine and improve patient outcomes.

  6. Indian Biosimilar Companies Are Poised To Succeed In The Global Market 3/31/2025

    For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.

  7. A 5-Step Guide To Achieving Your Biosimilar Milestones On Time 3/24/2025

    As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.

  8. The Patent Cliff Looms – Design Your Biosimilar Approach Accordingly 3/3/2025

    In your pursuit of developing a high-quality biosimilar, think strategically. Consider what type of biologic your team’s expertise can support and which is needed most in your target market.

  9. Comprehensive Services For Ophthalmic Drug Development 2/20/2025

    To maximize bioavailability while preserving vision and maintaining the structural integrity of the eye, formulation and delivery strategies must be meticulously designed.

  10. The Complexities Of Early Phase Ophthalmic Drug Development 2/20/2025

    Navigating the landscape of ophthalmic drug development can be challenging. Check out this scientific journal that outlines potential challenges, and how to overcome them.