Extractables and leachables (E&L) studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging. Extractables & leachables testing services play a pivotal role in ensuring the safety and quality of healthcare products. A proper evaluation is a key requirement for most regulatory bodies, including FDA and EMA.
The heightened and increasing demand for biopharmaceutical medicines has resulted in greater demand for E&L testing in drug safety, such as when mitigating cross-contamination risks. Companies will have to sharpen their understanding of evolving E&L regulatory expectations in order to remain compliant - Industry testing experts play a crucial role in achieving success.
Trusted Leader in Extractables and Leachables Testing
With a strategic focus on quality and reliable services, we have established the most complete variety of extraction and testing options to meet your extractables and leachables needs. Through the provision of well-engineered and innovative testing solutions, we have gained the confidence of international manufacturers and regulatory agencies.
With over 15 years of experience, we offer the highest standards on extractables studies on primary packaging, medical devices, biologics, single-use systems (SUS) and other consumables used in the pharmaceutical manufacturing chain (filters, tubes connectors,ecc), as well as leachables testing in the final product. Thanks to our dedicated team of 40+ expert toxicologists and consultants, we can address all the issues associated to toxicological safety assessment.
Our dedication on offering exceptional testing services, fuels our commitment to contribute on the best practices and strategies to increase the efficacy in extractables and leachables testing. Let us develop with confidence your next project!
Discover the advantages of partnering with us for your regulatory success.
