Government

WHITE PAPERS AND CASE STUDIES

• Disclosure Management System: Build Or Buy?

  Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

• Improving Patient Health And Safety: Medical Affairs

  A medical affairs department needed leaders with scientific and project management expertise. With no time for training or risk tolerance, a consultant was hired to align activities with development and launch plans.

• 15 Reasons To Implement RFID In Medical Devices

  Discover the importance of integrating RFID technology into medical devices for improved tracking, supply chain management, and patient safety — enhancing security, traceability, and compatibility.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• Electronic Batch Reporting

  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.

• Digital Transformation Of WWTPs

  The importance today of wastewater treatment plants (WWTPs) is clear, as complex systems made up of different processes whose objective is to eliminate all or part of the pollution present in water, becoming a valuable asset for sustainability and the circular economy.

• Building Digital Capabilities For An Intelligent Tomorrow

  Explore how modern manufacturing software is transforming operations with AI-driven insights to empower CDMOs and CMOs to boost efficiency, agility, and client satisfaction in a competitive landscape.

• CHO Media Screening Success Using Benchmarking Studies

  Explore the challenges of media screening and a straightforward approach for saving time, reducing risks, and improving outcomes.

• Trial Rescue: Leadership Approach To Propel Clinical Development

  Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.

• Operationalizing Disclosure Intelligence For Compliance At Scale

  Learn how sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this challenging landscape.

• Criticality And Risk Analysis Helps Mojave Water Agency Optimize Maintenance Activities And Realize Cost Savings

  Amid a decrease in water supply and reliability, the MWA has seen a rise in costs and operational challenges related to regional expansion, increased regulatory requirements, climate change, and aging infrastructures. Despite these challenges, the MWA remains committed to managing groundwater basins sustainably, importing water responsibly, and proactively addressing risks using sound scientific practices.

• Six Benefits Of Automating A Manual Quality Management System

  Manual processes often lead to inefficiencies and increased errors. Discover the six benefits of automating a Quality Management System to improve accuracy and enhance compliance.