Regulatory Toxicology Services - Overview
Toxicological risk assessment (TRA) of pharmaceutical impurities, ExTractable, and Leachables (E&L) from Container Closure Systems (CCS), and the determination of Health-Based Exposure Limits (HBELs) such as Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE), Occupational Exposure Limits (OEL), and F-value for Child-Resistant Packaging (CRP) are highly essential to ensure Regulatory compliance with applicable requirements and standards.
TRA is a highly scientific activity requiring a thorough understanding of the pharmacology, pharmacokinetics, toxicology, and Regulatory aspects of pharmaceuticals. Freyr's highly experienced and board-certified toxicologists (DABT and ERT) have supported numerous such assessments for clients across the world. We deliver comprehensive TRA reports in full compliance with the latest Regulatory requirements.
Freyr’s expertise in the following areas has been well-recognized across the pharmaceutical industry:
- HBEL Reports - ADE/PDE, and OEL determination services
- TRA of impurities, Extractables & Leachables (E&L)
- Genotoxic impurities risk assessment in compliance with ICH-M7
- Toxicological risk assessment of impurities in drug substances (ICH Q3A) and drug products (ICH Q3B)
- 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
Freyr’s Regulatory Toxicology Services
Regulatory Toxicology Services
- Well-qualified (DABT and ERT) and highly experienced team of toxicologists
- Experience in handling complex risk assessments with high-quality scientific documents
- Ability to handle high volumes and multiple requirements simultaneously
- Unlimited Regulatory queries or audit support without any additional cost
- On-time delivery as per client requirements, including priority deliveries
- Well-established systems and processes from initial planning to final document submission
- Quality checks to ensure the accuracy and reliability of the data
- Expert review by highly experienced toxicologists to ensure the accuracy and consistency of scientific interpretations and conclusions
- Reports reviewed and approved by board-certified toxicologists (DABT or ERT)
