Our toxicology and regulatory consulting services
Karamella Consulting Inc. provides senior scientific expertise to deliver the following toxicology and regulatory consulting services:
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Scientific investigations
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Toxicology reports and recommendations
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Peer reviews
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Toxin exposure assessment, including for mold, drugs and occupational hazards
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Hazard identification
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Risk assessment
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Product safety evaluation
- Natural Health Products (NHPs)
- new pharmaceutical active ingredients
- polymers
- agri-chemicals (pesticides, herbicides)
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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
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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
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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
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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.