ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Quality Assured: Bringing Life-Changing Therapies To Patients

  Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.

• Planning For The Return And Destruction Of Your Product

  Aspects of accountability, reconciliation, return, and destruction require significant effort to compile historical data. A little up-front planning can remove many future complications.

• Outsourcers Are Feeling Uneasy About Continuity Of Supply

  Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.

• Optimized Laboratory Kitting Is Key To Successful Clinical Trials

  Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.

• 7 Key Considerations For Designing The Optimal IRT/RTSM

  Sponsors can create IRT/RTSM systems that are not only efficient and reliable but also adaptable to the evolving needs of clinical research by focusing on these seven key considerations.

• Is Your Clinical Supply Strategy Ready For EU CTR?

  One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

• The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective

  Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.

• How CDMOs Deliver Precision and Scale in Pharma Spray Drying

  Spray drying depends on precise control, scalable methods, and solid quality systems. Strong design and GMP‑aligned execution help reduce risk and move complex compounds forward efficiently.

• Optimizing Clinical Supply Management With A One-Team Approach

  See how NewAmsterdam Pharma managed 11 global studies across 51 countries and 835 sites for 12,000+ patients without overwhelming their internal team.

• Risk Mitigation Planning For Pharmaceutical Tariffs

  Examine the potential ramifications of proposed tariffs on the pharmaceutical and biotechnology sectors, highlighting critical concerns regarding national security and supply chain stability.