Regulatory Affairs White Papers & Case Studies

  1. Optimizing Early-Stage Oncology 1/14/2025

    A strategic partnership enables a U.S. biotech company to address the struggles with their Phase I first-in-human oncology trial.

  2. Global Start-Up For Multinational Geographic Atrophy Trial 6/26/2025

    This partnership allowed a leading biopharmaceutical company to navigate the complexities of a Phase IIb study investigating a novel pegylated RNA adapter for geographic atrophy secondary to dry AMD.

  3. CAR-T And Laminar Flow Glovebox Isolators 6/6/2024

    A request was made for a containment system that would protect operators during lentivirus transfer, as well as provide a controlled environment for IL-2 charging of media, bead addition, and blood bag spiking.

  4. Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements 6/19/2024

    Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.

  5. Electronic Batch Reporting 1/22/2024

    Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

  6. Container Closure Integrity Test Method Development For Autoinjectors 8/6/2025

    Discover an autoinjector technology that leverages laser-based headspace analysis for container closure integrity to advance biologic drug delivery with precision, safety, and regulatory confidence.

  7. Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines 8/2/2024

    Learn how a leading CDMO partnered with Körber to quickly deploy a high-speed packaging solution to meet tight production deadlines in the face of a global pandemic.

  8. Multiple Fill Line Delivery Experience 8/16/2025

    Learn how a multinational pharmaceutical company successfully implemented a global strategy for insulin cartridge filling, achieving seamless regulatory approval with zero deviations.

  9. Vaccine Fill Line Operations 11/24/2025

    Learn how adopting a harmonized, risk-based validation strategy across global sites can reduce operational readiness timelines and drive improvements in equipment effectiveness and regulatory compliance

  10. Developing A Project Management Office (PMO) At A Small Manufacturing Site 8/11/2025

    Discover how implementing a Project Management Office transformed a small manufacturing site into a high-performing, strategic asset within a global network.