Insights On Regulatory Compliance

  1. A Roadmap To Expedited Review Pathways 6/12/2025

    Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

  2. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

    Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

  3. Combination Products: Navigating Regulatory Strategy, Design Verification 5/19/2025

    Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

  4. 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.

  5. FDA Recall Prevention: Save Time, Money, And Reputation 10/8/2024

    FDA product recalls pose significant challenges for life sciences companies. Avoid recalls with these actionable steps to mitigate risk, ensure compliance, and safeguard your organization's reputation.

  6. Controlling Comment Chaos: A Medical Writing Leader's Story 7/14/2025

    Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.

  7. Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities 6/12/2025

    Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

  8. 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.

  9. Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation 9/17/2025

    Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.

  10. The Roadmap To Asset Performance Management In Life Sciences 8/12/2025

    Find out how asset performance management boosts reliability, compliance, and efficiency in life sciences, which guides organizations from reactive fixes to predictive optimization.