Testing Service Category: Testing Service Child Post
September 28, 2018
Study Design
Understanding Biocompatibility in a Risk Management Context As part of a biocompatibility evaluation, ToxSmart reviews the design and intended use of a medical device, as well as the previous biocompatibility data for the device or a similar device. Based on this assessment, we provide our recommendations for completion of the biological safety evaluation, which may […]
Full StorySeptember 28, 2018
Regulatory Strategy
Understanding Regulatory Review Program success is determined by satisfying the regulatory review who have demands that are shaped by key opinion leaders (KOLs). ToxSmart stays current with trends in regulatory guidance through frequent communication with these thought leaders; this often leads to positive, science-driven interactions with regulatory agencies. Our subject matter experts can help you […]
Full StorySeptember 28, 2018
Gap Analysis
Understanding Gap Analysis Life science product developers want to ensure that their historic testing results are still compliant with contemporary testing standards. Manufacturers may also want to verify that their testing program is complete for the classification of their device. Gap analysis helps them maximize the use of historical data and refine their current testing […]
Full StorySeptember 28, 2018
Toxicological Risk Assessment (TRA)
Understanding Toxicological Risk Assessment (TRA) TRA is a research-based evaluation comprised of four activities: hazard identification and data evaluation exposure assessment dose-response analysis risk characterization The risk assessment is based on a chemical characterization of the test article, published information from the toxicological literature, and tolerable exposure limits, which may be adopted from published guidelines […]
Full StorySeptember 28, 2018
Microbiology Custom Studies
September 28, 2018
US FDA CFR Testing
September 28, 2018
European Pharmacopoeia Testing
September 28, 2018
Japanese Pharmacopoeia Testing
September 28, 2018
Device Implantation
September 20, 2018
Support Services
State of the art facilities with comprehensive surgical support services. Our facilities offer the capabilities to handle large and small animal models. Alongside our two vivariums, our fully equipped surgical and procedure spaces offer the latest in surgical equipment, monitoring, and imaging. Toxikon’s special support services can provide full hematological assessments, biochemistry, analytical, and histopathology […]
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