Regulatory Affairs White Papers & Case Studies

  1. Understanding Real-World Patient Characterization And Safety Outcomes Of DEXTENZA 5/8/2025

    In this study, we can derive confirmation of DEXTENZA’s favorable safety profile across a broader surgical spectrum.

  2. Difco TC Yeastolate Ultra-Filtered (TCY UF) In Scale-Up Optimization 10/30/2024

    Explore how Difco™ TC Yeastolate ultra-filtered (TCY UF) enabled over 100% improvement in titer for CHO cell culture through feed optimization and bioreactor scalability in a real-world application.

  3. Enhance Access And Improve Retention In Rare Disease Trials With HTS 4/17/2025

    Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.

  4. CAPA Management Improvement Process 9/15/2023

    Gain insight into how a small team of experts worked to collect, trend, and understand the CAPA generation and completion process of a client struggling with on-time batch release, missed CAPA closure deadlines, and more.

  5. Efficient Data Aggregation And Oversight: A CRO Success Story 4/22/2024

    Explore how a full-service CRO and tech-driven life sciences provider streamlined data aggregation and clinical trial oversight, yielding significant time and cost savings.

  6. When Beer Becomes Hazardous Waste 5/12/2023

    Faced with restaurants and bars suddenly closed for the foreseeable future due to COVID-19, a beverage distributor was forced to take back 40,000 gallons of expired beer. 

  7. Regulatory Affairs Project Manager 5/28/2024

    Discover how a ProPharma consultant effectively integrated tools, streamlined processes, and enhanced communications within a biotech company to ensure regulatory filings would be delivered promptly and with the highest level of quality.

  8. Proactive WWTP Design And Innovation Improves Health Of Chesapeake Bay Watershed 2/2/2023

    Read about the $568 million, decade-long upgrade of a Water Pollution Control Plant that would expand the plant’s capacity from 30 mgd to 40 mgd while also reducing nitrogen and phosphorous to the limit of technology.

  9. Monoclor® Residual Control Manages Residual For Problematic 5.5 Million Gallon Tank For Eastern Municipal Water District 12/21/2023

    Eastern Municipal Water District (EMWD) serves about 142,000 customers in Riverside County, California. The EMWD service area is one of the largest for any water district in arid southern California. On the drinking water side, EMWD manages two water treatment plants and over 15 reservoirs. With 70% of the district’s water coming from the Metropolitan Water District with chloramine disinfection, EMWD has become reliant on chloramine disinfection to manage long transmission lines and longer detention times due to on‐going water scarcity.

  10. Poultry Panic: Urgent Wastewater Fix Saves Poultry Plant From Fines 8/9/2024

    On a late Friday afternoon in June, a call came in to USP Technologies (USP): a major poultry processing plant in the southeast was in danger of violating their wastewater discharge permit.