Toxicological Services – Risk Assessment
Science-Driven Risk Evaluation for Safe and Compliant Products
Toxicological Risk Assessment (TRA) is essential for ensuring the safety, compliance, and regulatory acceptance of pharmaceuticals, medical devices, chemicals, cosmetics, and consumer products.
At ToxExel Solutions, we provide scientifically robust and regulatory-aligned toxicological risk assessment services to support product development, regulatory submissions, and global market access.
What Is Toxicological Risk Assessment?
Toxicological Risk Assessment is a structured scientific process used to evaluate the potential adverse health effects of chemical substances under defined exposure conditions.
It integrates:
- Hazard identification
- Dose-response evaluation
- Exposure assessment
- Risk characterization
This approach helps establish safe exposure limits, acceptable intake levels, and scientifically justified margins of safety.
Our Toxicological Risk Assessment Expertise
We provide end-to-end toxicological risk assessment services aligned with international regulatory expectations.
Hazard Identification
- Review of toxicological profiles from published literature and scientific databases
- Evaluation of systemic, local, genetic, and reproductive toxicity
- Assessment of carcinogenicity and genotoxicity risks
Dose-Response Assessment
- Determination of NOAEL, LOAEL, and benchmark dose values
- Establishment of Acceptable Daily Intake (ADI)
- Permitted Daily Exposure (PDE) calculations
- Threshold of Toxicological Concern (TTC) evaluations
Exposure Assessment
- Estimation of patient and user exposure through oral, dermal, and inhalation routes
- Worst-case and realistic exposure scenario analysis
- Product-specific exposure modeling
Risk Characterization
- Margin of Safety (MoS) calculations
- Weight-of-evidence toxicological assessment
- Identification of data gaps, uncertainties, and regulatory concerns
Key Applications of Our Toxicological Services
Pharmaceuticals
- Impurity and containment risk assessments for genotoxic and non-genotoxic impurities
- ICH M7 and ICH Q3A/Q3B/Q3C compliance support
- Extractables & Leachables (E&L) toxicological risk assessments
- Predictive toxicology using QSAR, read-across, and in silico tools
Medical Devices
- Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) under ISO 10993
- Chemical characterization support under ISO 10993-18
- Toxicological Evaluation Reports (TER) under ISO 10993-17
Cosmetics & Personal Care Products
- Ingredient safety assessments aligned with EU SCCS guidelines
- Margin of Safety (MoS)-based safety justifications
- Exposure-based cosmetic risk evaluations
Chemicals & Industrial Products
- REACH compliance and chemical safety reporting
- Occupational exposure risk assessments
- Predictive toxicology and read-across assessments
Regulatory Alignment
Our toxicological risk assessment services are aligned with global regulatory frameworks and scientific guidelines, including:
- ICH guidelines (M7, Q3 Series)
- ISO 10993 biocompatibility standards
- OECD principles and test guidelines
- US FDA and EMA guidance documents
- EU SCCS cosmetic safety guidelines
- REACH and regional chemical safety regulations