The Three Keys To E&L Success: Study Design, Partner Selection, And Timing

By Vicki Ward, Ph.D., Director, Pace® Life Sciences

Extractables and leachables (E&L) programs are most effective when they are treated as strategic risk management—not just a submission requirement. Success often depends on decisions made before samples reach the lab: defining what the data must support, aligning study design with product stage and regulatory pathway, and focusing characterization efforts where risk is highest. A one-size-fits-all approach can create unnecessary testing, missed concerns, or data packages that fall short of regulatory expectations. Strong partner selection also matters, because E&L work can require analytical chemistry, material science, toxicology, regulatory strategy, and manufacturing insight. Timing is equally critical. When E&L planning begins only near a regulatory milestone, compressed schedules and unexpected findings can create avoidable risk.

Early planning gives teams more flexibility to evaluate materials, align studies with development milestones, and address concerns before they become critical-path issues. Access the full article to learn how better design, partnership, and timing can strengthen E&L outcomes.