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WHITE PAPERS AND CASE STUDIES

• Global Resourcing Maximizes PV Operations To Meet Timelines

  Explore how clients were able to leverage the extensive resources of PPD FSP Solutions to maximize their PV operational delivery model and successfully meet ambitious timelines.

• Preparing CRAs For Success In Oncology: Targeted Training In An Era Of Advanced Therapeutics

  Explore the pivotal role of Clinical Research Associates (CRAs) in oncology clinical trials, emphasizing their critical responsibilities and the importance of specialized CRA training programs.

• Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

  Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing

  Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

• Accelerating CRO Study Deployment At Scale

  A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.

• Biopharma Production And Quality Control With Electrophoresis

  Discover how Kaneka Eurogentec, a leading provider of custom DNA synthesis and molecular biology services, enhanced their fragment analysis to achieve higher efficiency and accuracy in their workflows.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.

• 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.

• Forge Boosts Efficiency And Compliance During External Collaboration

  Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

• Increasing Batch Size And Reducing Cycle Times For A Biologic

  JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.