Government

WHITE PAPERS AND CASE STUDIES

• Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends

  Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

• Extra-Terrestrial Connections: Enabling Optical Mesh Networks In Orbit

  Optical filter implementation into orbital mesh networks must consider how price, performance, and delivery timeline can be optimized together to align with specific customer needs.

• 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.

• 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.

• 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.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Meet Regulation Requirements With RTU Vials And Cartridges

  Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.

• 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.

• Navigating Sensitive Country Requirements

  See how Scout expertly navigated complex regional laws and regulations to allow study patients in Iran access to treatment in Turkey.

• 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.

• From Open Cleanrooms To Closed Systems – What Is Driving The Change?

  Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

• Does Asset Health Monitoring Have A Role In The Water Sector?

  See why collaboration with trusted vendors is crucial for deploying reliable, adaptable, and sustainable asset health solutions in the evolving water sector.