Cell and Gene Regulatory

  1. 3 Strategies To Protect Quality, Ensure Compliance And Drive Performance 11/24/2025

    Discover strategies to calibrate testing scope to risk, optimize execution workflows, and reduce operational burdens without compromising quality standards or safety compliance.

  2. Speed Meets Precision With Process Development Services 11/24/2025

    Explore strategies to accelerate biosimilar development that help manufacturers reduce timelines, optimize workflows, and meet regulatory standards while delivering cost-effective therapies.

  3. The Promise And Paradox Of QbD 11/24/2025

    The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

  4. Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk 11/21/2025

    Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.

  5. Here's What You Need To Know About The Access Consortium Pathway 11/20/2025

    Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

  6. Unlock Robust And Reliable Stability Data With The Right Partner 11/19/2025

    Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

  7. Empowering Patients And Tackling Orphan Drug Development Challenges 11/18/2025

    Successful rare disease trial design requires patient-centric approaches. Experts share how to embed the patient voice, optimize site readiness, and balance feasibility with essential regulatory rigor.

  8. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

    A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

  9. The Growing Complexity Of Conducting Oncology Trials 11/17/2025

    As diversity plans and multi-regional considerations become core to trial design, early-phase oncology programs must navigate a landscape that offers unprecedented opportunity.

  10. Dose Optimization: A Strategic Lever In Oncology Drug Development 11/17/2025

    Targeted therapies, immunotherapies, antibody–drug conjugates, and other biologics demand a patient-centered strategy that recognizes that higher doses do not always translate to better outcomes.