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.

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 in full compliance 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

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
  • 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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Celebrating Customers Success

 

Medicinal Products

Medical Writing

India

A big thanks to Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward for a continuous business association with Freyr.

Head of Quality Assurance

 

Medicinal Products

Medical Writing

India

A big thanks to the Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward to a continuous business association with Freyr.​

Head of Quality Assurance​

India-based, Leading Pharma Contract Manufacturing Organization​

 

Medicinal Products

Medical Writing

UK

We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals. Look forward to your perennial support and our continued relationship and beyond. ​

Global CMC Technical Lead​

China-based, Leading Innovator Pharmaceutical Company​

 

Medicinal Products

Medical Writing

USA

Thank you, Freyr team. I appreciate your professionalism, dedication, and hard work. You’ve gone above and beyond to ensure all deliverables were met ahead of schedule throughout the project and have done a great job managing a challenging group of products. I appreciate your attention to detail and follow-up on the large workload you’ve managed. It’s been a pleasure working with you, and I wish you and your family all the best in the future!​

Director, Global Labeling Management – Labeling Cluster Head Global Product ​ Development, Global Regulatory Affairs

US-based, Multinational Pharmaceutical and Biotechnology Company​

 

Medicinal Products

Medical Writing

Vietnam​

Thank you so much for being a great partner in our Regulatory compliance journey.

As Asian countries move towards having safety assessments as a key requirement, your support has helped us significantly in fulfilling those requirements well ahead of our competitors in Vietnam. ​

In fact, I shared your contact with our regulatory officers so that they can share it across the industry if the safety assessments become necessary.

Lead, R&D/Personal Care

India-based, Multinational Consumer Goods Company​

 

Medicinal Products

Medical Writing

USA

Kudos to you all for the brilliant teamwork !! Alone, we can do so little; together, we can do so much.

Look forward to the next milestone and collaboration on new projects in the future.

SVP - R&D ( Finished Dosage Form)​

US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​