Insights On Regulatory Compliance

  1. Scientific Literature Reviews And AI's Potential For Evidence Synthesis 4/14/2025

    Scientific literature reviews are crucial for HEOR decision-making but notoriously slow. Explore how AI can potentially accelerate evidence synthesis while maintaining necessary scientific rigor.

  2. Harmonizing Regulatory Guidelines For Assay Validation 7/24/2024

    Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.

  3. 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.

  4. Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements 4/8/2025

    Viral Disinfectant Efficacy Studies validate cleaning protocols in pharma facilities, ensuring regulatory compliance, reducing contamination risk, and supporting safe, effective disinfection with expert CRO guidance.

  5. Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials 5/12/2023

    Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

  6. Deviation And Change Control In Pharmaceutical Manufacturing 9/20/2024

    Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.

  7. Introducing Laminar Airflow Technology In Aseptic Processing 8/21/2023

    The global market for injectable drugs will reach $69.13 billion by 2028. Examine the vital role of laminar airflow technology in meeting sterile integrity standards and minimizing contamination risks.

  8. 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.

  9. Key Takeaways From PDA Ireland Microbiology Event On Innovation And Technology 4/14/2025

    Insights from a PDA Ireland event reveal how innovative technologies like VR and automation are transforming sterile manufacturing, improving efficiency and addressing contamination control strategies.

  10. Kneat Solutions Bio-Expo Live February 2025: Quality, Data, And Analytical Solutions 3/17/2025

    Discover how top pharma companies streamline validation, reduce cycle times by 40%+, and ensure compliance with a digital validation platform that also aids in real-time reporting and compliant testing.