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.