Give your device a healthy start
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Tests designed by our specialists with a custom approach, keeping regulatory requirement criteria in mind
Studies conducted with proprietary methods of screening for the high level of quality you expect
We pursue the answers you need to provide clarity throughout the entire preclinical testing process
Understanding the chemical makeup of your device or combination product and its effect on the body is an important component of your product’s preclinical testing. Every medical device program needs to evaluate the materials that have direct or indirect bodily contact and meet regulatory standards using standardized analytical chemistry methodologies.
We conduct all of our analytical chemistry studies using proprietary methods of screening or a variety of compounds—providing the high level of quality you expect.
Whether your device is simple or complex in nature, we partner with you to establish the best plan and study needed for achieving regulatory approval. Our deep experience in analytical chemistry includes:
Extractables and leachables (E&L)
Manufacturing residual testing
Dose verification and validation
Storage and stability testing
A wide array of validation methods
We know that your medical device or combination product has the potential to bring greater outcomes to patients in need. That’s why we share your urgency to advance your medical devices and combination products. Whatever your goals and milestones, we’ll help you reach them on time. From developing clear road maps to communicating proactively, we work with speed and efficiency at every turn to keep pace with your important milestones.
Our vast portfolio of analytical chemistry testing services has you covered in whatever you need:
