Featured Articles

1. Successfully Navigating Opportunities With On-Body Delivery Systems 4/23/2026

   Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu addresses some of the most frequently asked questions about on-body delivery system requirements.

2. Implementing Medium And High-Volume Drug Handling And Packaging Programs 4/23/2026

   Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.

3. Robotics And AI In Pharma: Driving The Next Wave Of Innovation 2/23/2026

   Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.

4. Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1 2/4/2026

   Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.

5. FAQs On The Revised EU GMP Annex 1: Volume 7 2/4/2026

   Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

6. FAQs On The Revised EU GMP Annex 1: Volume 8 2/4/2026

   Successfully implementing a site-wide CCS requires prioritizing barrier technologies, integrating primary packaging into risk assessments, and adopting a data-driven approach to environmental monitoring.

7. Designing Robust Studies To Meet Auto-Injector Performance Requirements 10/30/2025

   Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.

8. Establishing And Safeguarding Shelf Life In Combination Products 10/27/2025

   Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.

9. A Pathway For Regulatory Success For Devices In Combination Products 10/27/2025

   Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.

10. FAQs On The Revised EU GMP Annex 1: Volume 6 9/21/2025

    The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.