Government

WHITE PAPERS AND CASE STUDIES

• Guide To Navigating The Complex And Expanding Regulatory Landscape

  In today’s complex landscape, organizations face growing compliance demands from diverse sources. Learn how a strong compliance system and culture of accountability drive sustainable growth and protect long-term success.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• FDA Recommendations For Gene Therapy For PMDs

  Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Three Key Strategies To Guide Efficient And Effective Recall Management

  Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

• 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.

• 4 Steps To Understanding The Quality Journey

  Explore a four-step framework for organizations to enhance quality management, emphasizing its importance in driving business success, customer satisfaction, and competitive advantage.

• Driving A High-Adherence LTFU Trial Without An EDC

  Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.

• The Evolution Of EAM/CMMS In Pharma Manufacturing

  Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

• The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• Placing Drug Strategies On A Solid Foundation For Success

  Explore how certain drivers are impacting traditional drug development strategies and relationships with outsourced drug development and manufacturing partners.

• Streamlining The Importing & Exporting Of Biological Samples

  Create a seamless and predictable import and export process by working with experienced bioanalytical laboratory partners, understanding what paperwork samples require, and proactive planning.