Insights On Regulatory Compliance

  1. Removing The Headache: Outsourced Stability Storage And Testing Solutions 12/4/2024

    Should you manage certain operations internally or partner with a trusted external provider? Watch experts discuss the benefits of outsourcing stability, storage, and testing.

  2. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

    The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

  3. Opportunities And Risks As Biosimilars Come Of Age 6/12/2024

    As biosimilars mature, they promise expanded patient access and healthcare savings. Despite regulatory hurdles, collaboration and innovation will drive their future growth and impact.

  4. When Should Filter Validation Be Performed? 8/21/2024

    Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

  5. Navigating EU GMP Annex 1 Revisions In Drug Manufacturing 11/27/2023

    Explore changes introduced by the revised EU GMP Annex 1, key considerations to maintain compliance, and stark statistics that underscore the consequences of non-compliance in this evolving landscape.

  6. Perspectives On Performance, Scalability, And Regulatory Compliance 10/28/2024

    Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

  7. Supplier Quality And The True Cost Of Recalls 2/20/2025

    Recalls can cost millions (or even billions) and threaten a company’s public perception. Discover how to minimize recall costs and enhance compliance with effective quality management strategies.

  8. Unpacking FDA's Final Rule To Regulate LDTs 3/14/2025

    Discover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.

  9. Bioproduction Analytics To Support Optimized Media Development 9/12/2023

    Designing and optimizing a cell culture medium can be a complex and time-consuming process, and accurate analytics are vital in streamlining media development to achieve long-term success.

  10. FAQs On The Revised EU GMP Annex 1: Volume 2 3/5/2025

    Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.