ToxSmartTM, Toxikon’s risk assessment consulting group, provides sponsors with dedicated resources to develop cost-effective, strategic approaches to material characterization prior to further investment. Our team of toxicologists, chemists, and regulatory experts will collaborate with you to ensure ISO 17025 compliance and avoid unnecessary testing.

The pathway to regulatory approval for medical products can be lengthy and expensive. Based on the FDA Biocompatibility Guidelines, it is essential to conduct your safety testing within a risk management context; this may be advantageous in reducing your time-to-market without compromising on safety. Our experienced staff will help guide you through every challenge relating to the preclinical process.

Consulting Services Include:

  • Toxicological Risk – Assessment
  • – Gap Analysis
  • – Regulatory Strategy
  • – Raw Material Safety Investigation
  • – Study Design for:
    • – Chemical – Characterization
    • – Extractables & Leachables
    • – Biocompatibility Testing
  • – 510(k) Submission Support
  • – Biological Safety Evaluations
  • – Biological Risk Assessment
  • – Technical Memos for Adverse Findings
  • – QSAR Analysis