Chemical sequence diagram

Our toxicology and regulatory consulting services

Karamella Consulting Inc. provides senior scientific expertise to deliver the following toxicology and regulatory consulting services:

  • Scientific investigations

  • Toxicology reports and recommendations

  • Peer reviews

  • Toxin exposure assessment, including for mold, drugs and occupational hazards

  • Hazard identification

  • Risk assessment

  • Product safety evaluation

    • Natural Health Products (NHPs)
    • new pharmaceutical active ingredients
    • polymers
    • agri-chemicals (pesticides, herbicides)
  • Regulatory compliance strategy, auditing and risk management to ensure products are approved and in compliance in all jurisdictions

    • Facility audits for Good Manufacturing Practices (GMP) for compliance and in support of facility establishment licences
    • Standard Operating Procedures (SOPs) audits for compliance with Health Canada regulations
  • New product approvals & registrations

    • Investigational New Drug submission review
    • New Substances Notifications
    • Natural Health Products (NPN) applications
    • Assistance with preparation of Scientific Research and Experimental Development (SR&ED) Tax Incentive Program claims
  • Expert witness and litigation support

    • Review of case information to determine scientific plausibility
    • Preparation of expert reports
    • Depositions and affidavits
    • Testimony at trials, hearings and review boards
    • Karamella Consulting has provided litigation support on the following issues:
      • occupational exposures
      • mold exposure
      • accidental poisoning
      • radioactivity
      • water quality
      • adverse effects of cosmetics
  • Expert panels, committees and advisory boards

    • Provides expertise for public health, environmental, and occupational health and safety issues on expert panels, committees and advisory boards for industry associations, government (federal, provincial, municipal) and First Nations.