Unlock Robust And Reliable Stability Data With The Right Partner

By Mahesh Koté, Senior Manager of Chemistry, and Kyle McQueen, Senior Stability Coordinator

With the 2025 release of the updated ICH Q1 Stability Testing of Drug Substances and Drug Products, drug sponsors now have access to thorough insight into how stability studies should be conducted, at what intervals, and which temperature, storage, and humidity conditions should be assessed. This internationally harmonized approach to stability testing and data collection for drug substances and drug products has been adopted by the EMA and FDA.

As regulatory expectations evolve, having a stability partner that offers robust infrastructure and scientific expertise can help you design studies strategically, maintain compliance, and accelerate product release. Whether you are submitting your DMF or NDA, stability studies are an essential component of securing FDA approval and establishing shelf-life data for your drug. To secure safety, durability, and compliance for your product, prioritize working with a knowledgeable testing partner that can guide your strategy and provide lifecycle support. Download the full article to learn more.