Regulatory Affairs White Papers & Case Studies

  1. Reshaping A Biopharma Drug Manufacturer's Real Estate Portfolio Strategy 11/29/2023

    From strategy to execution and implementation, learn about the partnership that allowed a biopharmaceutical drug manufacturing company to modernize its real estate portfolio and achieve its strategic goals.

  2. AFC SEMPER RPM Offers Water Hammer Insight For Monroe, North Carolina 3/28/2024

    Discover how the implementation of pressure sensing technology has allowed the city of Monroe, North Carolina to gain greater insight into its distribution system and why main breaks were occurring.

  3. Maintaining Quality And Regulatory Compliance To Support Rapid Global Growth 2/7/2025

    Discover how Huvepharma, a global pharmaceutical company, implemented software to standardize quality management processes across its manufacturing sites, enhancing compliance and efficiency.

  4. Mobile Clinical Lab For Miami Cancer Institute 6/6/2024

    Germfree helped the Miami Cancer Institute at the peak of the COVID pandemic convert a pharmacy compounding mobile unit to a BSL-2+ mobile clinical lab for in-house testing for COVID testing.

  5. A Biosafety Cabinet For Virology Studies And Disease Surveillance 6/19/2024

    Discover how Germfree tackled a unique challenge from the Public Health Agency of Canada by designing a custom Class III biosafety cabinet for advanced virology studies and disease surveillance.

  6. Breaking Barriers In Malaria Prevention With A Mobile Cleanroom 6/19/2024

    The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

  7. Sulzer Dewatering Pumps Acclaimed By Pump Renter Neptune 6/28/2023

    Neptune required a partner who can provide reliable technical innovations and proven solutions in wastewater and dewatering. Learn why they chose Sulzer as a partner in this collaboration.

  8. Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology 5/2/2025

    Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.

  9. ProPharma Supports A Contract Manufacturer's Form 483 Response 9/10/2024

    Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

  10. Optimizing End-To-End Processes To Reduce Costs And Improve Yields 11/30/2023

    Explore the challenges faced by a large CDMO as well as the solutions that were provided to achieve significant time savings, cost savings, and the removal of a major downstream process limitation.