ToxHub has joined the SenzaGen Group as independent regulatory toxicology experts. Our customer-centric in vitro testing services and cutting-edge GARD® technologyies have been complemented by ToxHub’s tailored toxicology advisory services. Based in Rome, Italy, ToxHub specializes in toxicological risk assessment and regulatory strategy consulting, with specific expertise in medical devices and pharmacology.
Founded by toxicologists with 25-years of experience in the pharmaceutical industry, ToxHub provides tailored and cost-effective toxicology advisory services to customers across industries. ToxHub’s risk assessment and regulatory compliance services include the following key areas:
- Hazard identification, hazard characterization including dose-response analysis to define a Point of Departure, exposure evaluation and risk characterization for pharmaceutical and non-pharmaceutical ingredients, chemicals, contaminants and impurities.
- Regulatory strategy advisory and compilation of regulatory documentation (IB, IMPDs, INDs, etc).
- Regulatory support when interacting with authorities, including responses to deficiency letters.
- Biological evaluation of medical devices (MDR).