Government

WHITE PAPERS AND CASE STUDIES

• 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.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• 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.

• How Sponsors Can Leverage New Technologies To Lower Trial Costs

  This study introduces sponsors to an innovative, lean, and efficient approach to data management that integrates site-facing technologies to streamline trial operations.

• Design Testing Strategies To Develop A Drug-Device Combination Product

  Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

• 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.

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• 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.

• 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.

• AMERICAN Plays A Role In Rebuilding Puerto Rico's Infrastructure

  AMERICAN is helping rebuild Puerto Rico’s vital water infrastructure after Hurricane Maria, supplying American-made products to strengthen resiliency for 3.5 million residents and millions of annual visitors.

• Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies

  Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.