CGMP Radiosynthesis: Will Your CRO Be There When It Counts?

Better Insight, Better Outcomes

Expert 14C radiolabeling for human clinical programs requires extensive training and experience. Having supported radiolabeled studies for more than 30 years, ABC Laboratories was one of the first to produce 14C-labeled API and formulate CTMs under CGMP requirements. Our experienced radiosynthethic chemists have worked with many drug candidates so we can help guide you through the detailed CGMP process. We work in tandem with your chemistry, regulatory, and QA personnel to ensure that a high-quality API or drug product CTM, that meets your specifications, is delivered to the clinic on time. Click here for more.

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.