Regulatory Toxicology Risk Assessment (TRA)
At Innomagine, we specialized in Regulatory Toxicology Risk Assessment (TRA)—a process critical for ensuring the safety and compliance of pharmaceutical products. From data assessment to risk mitigation and regulatory documentation, our board-certified toxicologists (DABT, ERT) leverage expertise in pharmacology, pharmacokinetics, toxicology, and global regulations to deliver accurate, globally compliant TRA reports. We help clients worldwide navigate complex requirements and drive safe, effective product development.
Comprehensive TRA Solutions for Global Compliance - As the pharmaceutical industry evolves, the need for Health-Based Exposure Limits (HBELs)—such as Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE), occupational exposure limit (OEL) and ‘F’-Value Reports. These scientifically established exposure limits are critical for cleaning validation, and ensuring regulatory compliance with EMA, FDA, OSHA, and ICH guidelines.
HBEL & Occupational Safety Services
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ADE/PDE, and OEL determination services
Impurities & Toxicological Risk Assessment
- Genotoxic impurities risk assessment in compliance with ICH-M7
- Toxicological risk assessment of impurities in drug substances (ICH Q3A) and drug
Toxicological Assessment
- Toxicological risk assessment of residual solvents (ICH Q3C)
- Toxicological risk assessment of elemental impurities (ICH Q3D)
- Toxicological risk assessment of E&L from the CCS
- Impurities in veterinary medicinal products (VICH GL18)
Environmental Risk Assessment (ERA) of medicinal products
F-Value Reports for CRP
