Government

WHITE PAPERS AND CASE STUDIES

• 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.

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• Providing Enhanced Manufacturing Data To Contracting Companies

  The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• Preparing For Disease X: Effective Vaccine Development In The Face Of A Future Pandemic

  CDMOs are playing a critical role in the global effort to prepare for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• 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.

• Breaking Through Barriers With Integrated Trial Optimization

  In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.

• The Evolution Of Clinical Operations And The Growth Of FSP Partnerships

  Explore the integration of new technologies, the FSP’s role in promoting patient diversity, and how clinical operations leaders are increasingly becoming thought leaders within the industry.

• 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.

• 5 Steps To Completing A Successful Root Cause Analysis

  Discover how Root Cause Analysis transforms manufacturing by addressing underlying issues and improving quality, which empowers teams to move from reactive fixes to strategic solutions.

• 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.