We provide leachables and extractables (E&L) services based on risk-based, lifecycle-integrated approach. The process starts with a review of the material and system characterization, such as packaging components, container-closure systems, processing equipment, and product-contact materials. The risk assessment is performed in a structured way to determine the possible sources of extractables, depending on the type of formulation, route of administration, and the exposure of the patient.

Our team develops an E&L strategy aligned with regulatory guidance (USP, ICH, EMA, FDA) (USP, ICH, EMA, FDA), study design, analytical, thresholds and reporting criteria. The process of vendor selection and coordination is handled to make sure that methods are suitable and regulatory. The extractables data is assessed to identify the possible leachable risks, toxicological assessment and safety qualification (where necessary).

Detailed documentation with risk justification reports and regulatory submission-ready reports are prepared. The inclusion of E&L in the early stages of development reduces unexpectedness at the late stages, facilitates the acceptance of submissions and patient safety without compromising efficient timelines and cost management.