##  [Regulatory Toxicology Services](/index%2ephp/medicinal-products/regulatory-toxicology-services) 

# Regulatory Toxicology Services

We develop high-quality risk assessment reports for pharmaceutical impurities, extractables, and leachables, as well as other potential risks to facilities and packaging materials.











- [Overview](#overview)
- [Services](#services)
- [Expertise & Advantages](#expertise)
- [Testimonials](#testimonial)
- [Insights](#insights)







## Regulatory Toxicology Services - Overview



Toxicological risk assessment (TRA) is a highly scientific activity that requires 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 assessments for clients worldwide. Our TRA reports are fully compliant with the latest Regulatory requirements.

Toxicological risk assessment (TRA of pharmaceutical impurities, extractables, 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 and standards.

Freyr’s toxicology services have been well-recognized in the following areas:

- HBEL Reports - ADE/PDE limits, 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



##### MPR - Medical writing Regulatory Toxicology Menu Block

- [ADE/PDE Determination/Report Services](/index%2ephp/medicinal-products/permitted-daily-exposure-pde-calculation)
- [F-Value Reports for Child Resistant Packaging (CRP)](/index%2ephp/medicinal-products/f-value-reports-for-child-resistant-packaging-crp)
- [Toxicological Risk Assessment (TRA) of Impurities, Extractables and Leachables](/index%2ephp/medicinal-products/toxicological-risk-assessment-services)
- [Environmental Risk Assessment (ERA) of Medicinal Products](/index%2ephp/medicinal-products/environmental-risk-assessment-era-of-medicinal-products)
 
 









## Regulatory Toxicology Services



- [Expertise](#mdv-1)
- [Advantages](#mdv-2)

- 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
- Regulatory queries resolution or audit support with expert insights



![Regulatory Toxicology Services]()





- 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)



![Regulatory Toxicology Services]()













### Ensure Regulatory Confidence with our Toxicology Support

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