White Paper

Q&A: Harmonizing Bioanalytical Method Validation – Navigating the Complex Landscape of Global Regulatory Standards

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Developing and introducing a new bioanalytical technique to the market is a time-consuming and expensive process, often taking years to meet regulatory benchmarks. The challenge intensifies when seeking approval in multiple markets simultaneously. The International Council for Harmonization (ICH) worked to address this issue, providing guidance starting January 21, 2023, to harmonize regulatory standards. While not universally adopted, many regulatory bodies consider ICH guidelines, facilitating greater harmonization and streamlining international approval processes. Adhering to these standards can significantly reduce time and costs in the clinical development pipeline. However, despite efforts, variations in interpretation still exist among bioanalytical testing facilities. Our recent white paper addresses common questions and suggests approaches to harmonize these differences. Download today for more information.


Associate Director, Method Validation
Associate Director, Method Development
Chief Scientific Officer, Large Molecule Bioanalysis

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