Are you confident your pharmaceutical, medical device, or packaging materials are free from harmful Leachables?

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We are excited to announce that we now offer Extractables and Leachables (E&L) Testing Services to support your product safety and regulatory compliance needs.

Our state-of-the-art analytical capabilities and experienced scientific team are equipped to help you:

• Assess potential Leachables from container-closure systems, medical devices, and drug-delivery systems.

• Meet regulatory expectations from the FDA, EMA, and other global agencies.

• Customize study designs based on your product type and risk level.

• Proactively identify and address potential safety concerns before product launch.

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Whether you are in early development or preparing for submission, our tailored E&L studies can help you:

• Identify and quantify Extractables and Leachables.

• Generate robust data for regulatory filings.

• Accelerate product timelines with confidence.

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We utilize a wide array of advanced analytical techniques, including GC-MS, LC-MS, LC-MS/MS and ICP-MS, operated by highly skilled scientists, to deliver accurate and defensible data.

Protect your products and your patients. Let us help you navigate the complexities of E&L testing. Schedule a consultation with our experts today.

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