Toxicology Consulting
Toxicology Consulting
Examples
Examples

Develop strategy to address toxicological requirements for reformulation of products, changes in packaging, switches

Prepare expert report to address potential toxicological issues:

    • Calculation and safety assessment of process impurities, residual solvents, degradants, and excipients e.g. flavors
    • Calculation and safety assessment of out of specifications (OOS) in impurities and degradation products

Comprehensive knowledge of Biological evaluation of medical devices according to ISO 10993-1

    • to develop strategy for biocompatibility testing
  •  
    • to address needs of Extractables and Leachables testing and risk assessment
  •  
    • to address requirements for biocompatability and risk assessment of packaging
  •  
    • to address requirements and strategy for changes to raw material, supplier or manufacturer
  •  
    • Preparation of Biological evaluation and  Toxicological assessment
  •  
    • Interaction with Notifying Bodie

Review of preclinical and toxicity information to identify potential red flags and develop strategy for mitigation