05.22.25 -- Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3

Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.

Understanding the key elements in the handover stage of a technology transfer is critical to your success. This is an overview of the Handover Stage of PDA TR-65.

Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

Investing in adaptable aseptic manufacturing pays off. Find out how flexible systems, despite higher initial costs, handle complex drugs and changing volumes to boost productivity and quality.

Read more about how to improve your patients’ outcomes, avoid costly delays to launch, and provide a better return on investment.

Comprehensive chemistry, manufacturing, and control (CMC) developability testing is essential to mitigate the risk of costly late-stage failures and to proactively address potential challenges.

Explore a process based on a series of inputs including the target product profile, drug properties, extensive past project experiences, technology maps, and absorption modeling.

Uncover a digital validation platform that delivers ROI by reducing costs through paperless validation, increasing efficiency, and aligning with organizational goals to accelerate life sciences transformation.

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

In designing a mixing process for scale-up, the power number is a critical parameter. Examine the determined power numbers for a single-use mixer at various mixing speeds and fill levels.

Learn more about the benefits of preparing liquid supplements in a multi-shaft mixer designed for bulk agitation, high-speed solids dispersion, and superior heat transfer.