Design and executeextractables andleachables(E&L) studies to supportinjectable biologicaldrug products, container closure systems, and medical devices.

Develop and authorE&L protocols, reports, and risk assessments in alignment with regulatory expectations.

Evaluateleachable profiles across stability studies, identifying trends and potential risks.

Conduct and/or oversee analytical testing using advanced instrumentation, including:

GC-MS, Headspaceand Direct Inject

LC-UV/MS, LC-MS/MS

High-ResolutionMass Spectrometry (HRMS)

ICP-MS (elemental impurities)

Identifyand characterizeunknown compounds using spectral libra...