Toxicological Risk Assessment (TRA) of Impurities, Extractables and Leachables

Trust Freyr for expert Toxicological Risk Assessment (TRA). Our certified toxicologists use validated tools and comprehensive strategies to evaluate impurities and E&L, ensuring Regulatory compliance and patient safety with quick turnaround and 24x7 support.

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Toxicological Risk Assessment (TRA) - Overview

Impurities in medicinal drug substances (API) or medicinal drug products, including Extractables and Leachables (E&L), not only affect the product quality but also pose a significant risk to the patient population. Toxicological Risk Assessment (TRA) of impurities, especially potential genotoxic impurities, is essential to control and/or limit its usage at unsafe levels.

Toxicological Risk Assessments of impurities and E&L are structured scientific processes involving hazard identification and risk assessment. For such risk assessment, ICH M7 recommended and validated tools are used in pharmaceuticals under the purview of Toxicological Risk assessment services.

Freyr’s toxicologist team under Toxicological Risk Assessments services has supported numerous global clients and addressed the issues associated with Toxicological safety Assessment and impurities in drug substances, drug products, residual solvents, process impurities and elemental impurities. 

Toxicological Risk Assessment (TRA)

  • Quality scientific and read-across strategies/approaches.
  • QSAR evaluation by using well-validated and Regulatory-accepted software tools by ICH M7 (statistical and expert rule-based evaluation).
  • Expert reports generated by ICH M7 with complete supporting data/information.  
  • Toxicological Risk Assessment and Derivation of Acceptable Daily Intake (ADI) for ‘out-of-specification’ impurities, including non-ICH Q3D elemental impurities.
  • Planning and designing of nonclinical studies for the qualification of impurities, including placement, monitoring, and review of study reports for Regulatory submissions.
  • E&L risk assessment in Pharmaceuticals and Medical Devices (ISO10993-17, ISO10993-18, and ISO/TS 21726).   
  • Highly experienced and board-certified team (American Board of Toxicology and European Registered Toxicologists).
  • A clear understanding of Toxicological Risk Assessment and E&L-relevant Regulatory guidelines and processes.
  • Comprehensive Toxicological Risk Assessment reports, encompassing detailed evaluation, hazard identification, and risk assessment.
  • Quick turnaround and priority delivery based on the urgency and requirement of the customer.
  • On-demand, short-summary reports with ‘Go-No-Go’ decisions.
  • Well-established and structured literature search strategy.
  • Robust quality control checks, right from document compilation to the sign-off stage.
  • 24x7 Regulatory support for audit queries on Toxicological Risk Assessment reports.

Partnering with Leading Organizations

 

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

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

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​