Leverage X Pharma Plus expertise in Regulatory toxicology to develop high-quality risk assessment reports, including Health-Based Exposure Limits (HBELs), for pharmaceutical impurities, extractables, and leachables, and other facility or packaging-related risk hazards.
Regulatory Toxicology
Services – Overview
Toxicological Risk Assessment (TRA) is critical for ensuring Regulatory compliance of pharmaceutical products.
Our services cover:
- ADE/PDE Determination and Reporting
- F-Value Reports for Child-Resistant Packaging (CRP)
- Toxicological Risk Assessment of Impurities, Extractables, and Leachables
- Genotoxic Impurities Risk Assessment (ICH-M7)
- Toxicological Risk Assessment for Drug Substances (ICH Q3A) and Drug Products (ICH Q3B)
- Residual Solvent Risk Assessment (ICH Q3C)
- Elemental Impurities Assessment (ICH Q3D)
- Environmental Risk Assessment (ERA) of Medicinal Products
- Impurities Assessment in Veterinary Products (VICH GL18)
TRA requires deep scientific understanding of pharmacology, pharmacokinetics, toxicology, and global Regulatory guidelines. X Pharma Plus board-certified toxicologists (DABT and ERT) bring extensive expertise, delivering precise, submission-ready TRA reports fully aligned with current Regulatory standards
Regulatory Toxicology Services
“Expert evaluation and documentation of non-clinical safety data to ensure compliance with global regulatory requirements and support successful product submissions.”