ChemTox™
Gezellig Scientific’s trademarked approach to chemistry testing, data analysis, and toxicological risk assessment. Pressure-tested through successful submissions to the FDA and Notified Bodies in Europe - ChemTox™ provides you with the confidence you need to make product-safety decisions.
The ChemTox™ Process
High-Quality Chemistry
All good solutions start with firm foundations. Through years of method development and validation work, the ChemTox™ approach the chemical analysis provides industry-leading turn-around-times while reducing unknown compounds. Great chemistry makes for effective risk assessments & provides you with the confidence you need to support regulatory submissions, biocompatibility assessments, process qualifications, and failure investigations.
Intelligence By Design
The ChemTox™ methodology was developed after years of research and work with leading medical device analytical chemistry laboratories to help make sense of toxicological data in a cost effective and time efficient manner. Through leveraging of custom-developed automated solutions, ChemTox™ generates a DABT-certified toxicologist-reviewed toxicological risk assessment (TRA) in a fraction of the time & expense of our competitors. By working with Gezellig Scientific, we provide end-to-end management of chemistry testing, data review, and generation of the risk assessment and report.
Rapid Decisions
ChemTox™ takes the guess work out of toxicolgocial risk assessments and puts you in the driver’s seat for product safety decisions. Testing and analysis take weeks to complete, not endless months, and keep your needs and budget in mind. We move at the speed of your business to ensure you have actionable when you need it. Our team of specialists provide bespoke service and analysis in the price and timeline of a commoditized service.
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 which it is needed.
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
ChemTox™ Plus
For more in-depth reviews and data support. This offering provides comprehensive data analysis, specialist review, extended documentation, and custom support.
Automated Analysis of Chemistry Data & Screening for “Red Flags”
Templated Toxicological Risk Assessment and Chemistry Testing Analysis
Board Certified Toxicologist (DABT) Data Review
Cursory Literature Review of Compounds Above Threshold of Toxicological Conner (TTC)
Utilization of QSAR & in Silico Techniques to Assess Compound Safety
Calculated Tolerable Exposure (TE) Limit for Compounds Above TTC
ChemTox™ Max
Our flagship tier, providing the needed detail to support regulatory review & product safety assessments.
Automated Analysis of Chemistry Data & Screening for “Red Flags”
Custom Toxicological Risk Assessment and Chemistry Testing Analysis
Board Certified Toxicologist (DABT) Data Review
Detailed Literature Review of Compounds Above TTC
Utilization of QSAR & in Silico Techniques to Assess Compound Safety
Calculated Tolerable Exposure (TE) Limit for Compounds Above TTC
Documentation of Detailed Analysis / TE for all Compounds Above AET
Audit / Submission Support