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The examination of Extractable and Leachable substances is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA.
Find out more about Extractables and Leachables.
Our expertise derives from Smithers' 90 year history of working with rubber and plastic materials, our medical and pharmaceutical industry experience and our excellent understanding of analytical chemistry.
Smithers has a wealth of experience to share, to support our clients to effectively and efficiently develop, test, validate and document their products for qualification and regulatory submission.
We understand that you have specific requirements that need to be addressed. Understanding E&L regulations, deciding on a suitable test strategy, and meeting timelines and resource restraints, can be a challenge for those new to E&L. Because we know that decisions made early in an E&L study will affect later stages, we can guide you through what is required, and how best to meet your needs, to support your regulatory submission and protect patients. We will:
- Listen to your requirements
- Understand your needs
- Advise on strategies
- Deliver your results
See how we can help with
- Extractables and Leachables testing and regulatory support more
- E-Cigarettes more
- Medical Devices and Combination Products more
- Single Use Systems and Processing Equipment more