ChemTox™ Core
An efficiently documented review of chemistry data to support medical device registration in Europe. No frills, no strings attached — the data you need in the manner in which it is needed.
- Chemical analysis utilizing exaggerated extraction protocols
- Heavy Metals, VOC, SVOC, NVOC in three (3) solvents*
- Automated analysis of chemistry data & screening for “Red Flags” associated with the EU MDR, REACH, RoHS, etc.
- Templated Risk Assessment and Chemistry Testing Analysis
- Board Certified Toxicologist (DABT) data review
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
ChemTox™ Plus
For more in-depth reviews and data support. This offering provides comprehensive data analysis, specialist review, extended documentation, and custom support.
- Chemical analysis utilizing exhaustive extraction protocols
- Solvent Compatibility (NVR), Heavy Metals, VOC, SVOC, NVOC in three (3) solvents*
- Automated analysis of chemistry data & screening for “Red Flags”
- Templated Toxicological Risk Assessment and Chemistry Testing Analysis
- Grouping of compounds by family to support further evaluations
- Cursory review of compounds above Toxicological Screening Limit (TSL)
- Board Certified Toxicologist (DABT) data review
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.
ChemTox™ Max
Our flagship tier, providing the needed detail to support regulatory review & product safety assessments.
- Chemical analysis utilizing exhaustive extraction protocols
- Solvent Compatibility (NVR), Heavy Metals, VOC, SVOC, NVOC in three (3) solvents*
- Automated analysis of chemistry data & screening for “Red Flags”
- Custom Toxicological Risk Assessment and Chemistry Testing Analysis
- Utilization of QSAR & in Silico techniques to assess compound safety
- Documentation of detailed analysis / TE for up to five (5) compounds above TSL
- Board Certified Toxicologist (DABT) data review
- Audit / Submission Support
*Heavy metals and volatile organic compounds are extracted in one (1) solvent.