Advancing Patient Safety

At Canyon Labs, we know that patient safety depends on more than just product performance—it requires a deep understanding of potential chemical risks intrinsic to materials of construction, processing, and interactions of the product with a patient’s body. That’s why our team provides comprehensive toxicological risk assessments (TRAs) to support medical device manufacturers, pharmaceutical companies, and packaging suppliers in meeting regulatory expectations with confidence.

A TRA is an essential step in product development and regulatory submission. Manufacturers pursue these assessments to:

• Demonstrate patient safety: Ensure that any potential chemical exposures from extractables, leachables, and residuals are within safe limits.
• Meet regulatory expectations: Global authorities such as FDA, EMA, and notified bodies require risk-based toxicological evaluations that conform to ISO 10993 and other standards.
• Streamline development: Identifying and addressing chemical risks early helps prevent delays later in the development process, regulatory submission problems, costly re-testing, or even product recalls.
• Support market access: A well-conducted TRA can provide confidence to regulators, healthcare providers, and patients alike.

By assessing exposure levels and comparing them to established safety thresholds, TRAs provide the scientific evidence needed to move products forward with confidence.

Our toxicology group is led by James Eucher, Cheryl Marker, and Jim Slota, each bringing decades of scientific expertise and regulatory insight:

• James – With a strong background in toxicology, biocompatibility, and regulatory science, James bridges technical depth with an understanding of evolving global standards.
• Cheryl – Known for her practical, solutions-focused approach to TRA challenges, Cheryl has guided numerous clients through complex submissions and regulatory reviews.
• Jim – A seasoned toxicologist with deep experience in chemical safety evaluations, specializing in compliance with ISO 10993 and related frameworks.

Together, their combined expertise allows Canyon Labs to deliver clear, defensible, and regulator-ready risk assessments tailored to your products.

• End-to-end support: From initial study design to final reports, the Canyon Labs team is here to help.
• Regulatory alignment: Deep knowledge of FDA, EMA, and ISO expectations,  with the ability to provide expert assistance if needed for regulatory body interactions.
• Practical insights: Risk assessments that are not only scientifically rigorous but also actionable.

By leveraging Canyon Labs’ toxicological expertise, you can streamline product development, reduce regulatory risk, and ensure patient safety remains at the forefront.