Our Services
Risk Assessments
We help you to document your E&L risks based on probability and severity, and provide solution focused recommendations to meet regulatory standards.
Extractables
We perform high quality extraction studies to assess the risk of harmful compounds migrating into your products.
Leachables
We conduct ICH compliant leachable studies on your behalf, providing expert advice and method development / validation to support you through the regulatory process.
Recycled Materials Support
We have experience screening recycled materials for regulated industries, and can help you evaluate whether post-consumer recycled materials are right for your medical and pharmaceutical products.
Advice & Training
We offer end-to-end E&L consulting services, including independent review of E&L reports generated by other providers. We have extensive experience supplementing existing studies and reports to achieve regulatory approval. We can also provide training, advice on material selection, and assistance with responding to regulatory queries. Even if the queries are not directly related to E&L – we can help!
Regulatory Compliance
We have experience working with the following regulatory standards, and can provide assistance with your regulatory submissions. USP 381; 661; 661.1; 661.2; 665; 671; EU MDCG 2020-5; MDR (2017/745); MEDDEV 2.7-1 rev 4; ICH Q3E; ISO 10993-18:2020(en); 21726:2019; PQRI; BPOG
Why choose Extractus?
We’ve been in your shoes! We have 45+ years combined experience in the pharmaceutical industry, working as Extractables and Leachables subject matter experts and outsourcing studies for some of the world’s largest pharmaceutical and consumer health companies. As such, we have a deep understanding of your needs, constraints, and regulatory requirements. We provide a fast, flexible, high quality, and solution-focused service to help you meet your targets on time, and within budget.
20 Years Experience
Excellent Service
Quick Turnaround
Flexibility
Led by industry veterans, Extractus delivers gold-standard Extractables and Leachables testing, combining cutting-edge technology, world-class expertise, and an unwavering commitment to quality. More than just data, we provide clear interpretation and strategic regulatory support, empowering you to make confident decisions. Unlike competitors that rely on hidden fees, outdated lab equipment, or underqualified staff, Extractus ensures you get accurate, reliable, and regulatory ready results that are right the first time, every time.
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