Insights On Regulatory Compliance

  1. Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections 12/20/2023

    Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.

  2. Achieving EU GMP Annex 1 Compliance For Contamination Control 3/4/2025

    Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products.

  3. Why Fill-Finish Strategy Can Make Or Break Your Drug Program 8/20/2025

    Sterile injectable success depends on early CDMO partnerships. The right fill-finish partner ensures sterility, flexibility, regulatory compliance, and scalability, transforming development challenges into efficient, patient-centered commercial success.

  4. Automated Bioburden Testing Solution 11/7/2025

    Automation is transforming microbial quality control labs, boosting productivity, minimizing errors, and ensuring data integrity. Discover how digitalization is driving Pharma 4.0 and reshaping lab workflows.

  5. Little Patients, Big Challenges: Developing Pediatric Formulations 5/12/2025

    Explore the development of high-quality, child-friendly oral formulations, as well as learn about new testing requirements for impurities and innovative approaches to creating age-appropriate medications.

  6. ICH Q9 Revision 1: Enhancing Quality Risk Management 8/12/2024

    ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

  7. MSD Global Digital Validation Rollout 12/17/2024

    See how MSD digitized global validation processes achieved over 50% cycle time reduction, streamlined workflows, improved compliance, and enhanced remote collaboration during COVID-19.

  8. Contamination Control Strategy With QRM Principles 11/19/2024

    Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

  9. Vision Inspection Software: The Missing Link In Digital Transformation 10/16/2025

    AI and MES can’t meet pharma’s visual inspection demands. Discover how purpose-built software ensures defect detection, compliance, and paperless quality for safer, more efficient operations.

  10. What Drug Manufacturers Should Know About Operational Readiness 6/4/2025

    Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.