Extractables & Leachables: Feeling Spooked by E/L Risk?

Let ABC Help Reduce the Risk of E/L Surprises.

When late in development, few unknowns are as worrisome as potential impurities from your packaging or delivery device. That said, it is well understood that container-closure systems can interact with even the most stable formulation. By applying Quality by Design (QbD) principles to your extractables and leachables program, the experts at ABC Laboratories will help reduce the risk of surprises and keep your NDA filing on track. Our approach combines a solid understanding of compound chemistry, careful analysis of potential E/L risks and well-thought-out study design to address regulatory data requirements in an efficient and cost-effective manner. Click here for more.