Extractable and leachable (E&L) safety assessments can be some of the most challenging review issues in an FDA application. That is because they require a coordinated effort between review staff from chemistry, manufacturing, and controls and toxicology. When should you begin your E&L studies? Do the FDA and EMA consider them differently? Learn the answers to these questions and more in this Q&A.
There is no shortage of guidance for conducting extractables and leachables (E&L) studies. The trick is aligning standards that overlap. This summary just scratches the surface of the complexity involved in extractables and leachables studies, but it shows the value of aligning different recommendations to form a coherent strategy.
Speed to clinic is crucial to a clients’ success, and a seamless package of CMC analytical development and testing as well as manufacturing services from early phase through commercialization can make that success possible.