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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 […]

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September 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 […]

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September 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 […]

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September 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 […]

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September 28, 2018

Microbiology Custom Studies

Customized Testing for Innovative Medical Products The diverse scientific capabilities within the department are leveraged appropriately to address each unique product requirement. With the emergence of complex devices, such as [...] Full Story

September 28, 2018

US FDA CFR Testing

Understanding CFR Testing The purpose of the study is to analyze total extractables. Extract solutions are evaporated to dryness and residues are weighed. Residue per surface area is calculated. Testing [...] Full Story

September 28, 2018

European Pharmacopoeia Testing

Understanding EU Regulatory Guidance for Pharmaceuticals The purpose of the tests is analyzing for relative differences in visual appearance, acidity/alkalinity, reducing substances, relative density, volatile matter, mineral oil, substances soluble [...] Full Story

September 28, 2018

Japanese Pharmacopoeia Testing

Understanding Japanese Regulatory Guidance for Pharmaceuticals The purpose of the study is to determine content of inorganic impurities in an organic substance. Testing categories and specifications Test NameSample NeededTurn-Around Time [...] Full Story

September 28, 2018

Device Implantation

Understanding Implantable Device Testing Services Implantation tests are in-vivo assays used to assess the local pathological effects on living tissue, at both the gross and microscopic level of a test [...] Full Story

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 […]

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