##  [Accelerating Toxicological Risk Assessment for Drug-Device Combination Products Within 48 Hours](/index%2Ephp/success-stories/accelerating-toxicological-risk-assessment-for-drug-device-combination-products-within-48-hours) 

# Accelerating Toxicological Risk Assessment for Drug-Device Combination Products Within 48 Hours

Delivering comprehensive toxicological risk assessment reports for a drug-device combination product within 48 hours, enabling rapid regulatory decision-making and compliance readiness.





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### 48-hour



turnaround time for complete Toxicological Risk Assessment delivery







### Comprehensive



impurity evaluation and leachables assessment completed







### 100%



regulatory-ready documentation supporting risk-based decision making













![Client Overview]()



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## Client Overview



An Australian pharmaceutical company specializing in veterinary pharmaceuticals required urgent toxicological risk assessment support for a drug-device combination product. The organization faced regulatory challenges related to leachable traces detected within the product and required a rapid, scientifically robust assessment to support regulatory decision-making and product compliance activities.











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## Background



The client identified leachable traces within a drug-device combination product and required a comprehensive Toxicological Risk Assessment (TRA) to evaluate potential patient safety risks. Given the critical timelines associated with product development and regulatory activities, the organization needed rapid access to toxicological expertise, scientific literature evaluation, impurity assessment, and risk characterization.

The assessment required a thorough review of toxicological data, evaluation of extractables and leachables, impurity identification, and determination of acceptable exposure limits while ensuring scientific rigor and regulatory acceptability.





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## Services in Scope



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Toxicological Risk Assessment (TRA) for a Drug-Device Combination Product



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Leachables and Impurity Evaluation



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Toxicological Data Review and Scientific Literature Assessment



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Risk Characterization and Safety Evaluation



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Regulatory Medical Writing and Report Preparation



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Rapid Turnaround Scientific Support















![Challenge]()



![Challenge]()

## Challenge



![Challenge]()

**Urgent Assessment Timelines**The client required a complete toxicological evaluation within an extremely short timeframe to support ongoing regulatory activities.





![Challenge]()

**Leachable Trace Identification**Detected leachable compounds required rapid toxicological evaluation and safety characterization.





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**Limited Time for Literature Review** Comprehensive scientific evidence needed to be sourced, evaluated, and incorporated within a compressed project schedule.





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**Regulatory Documentation Readiness**The final assessment required scientifically robust documentation suitable for regulatory review and decision-making.















![Challenge]()

## Solution



1

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##### Rapid Project Mobilization

Freyr assembled a multidisciplinary toxicology and medical writing team to initiate the assessment immediately and support accelerated delivery timelines.





2

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##### Comprehensive Toxicological Evaluation

Experts conducted detailed reviews of available toxicological data, impurity profiles, exposure assessments, and safety thresholds for identified leachables.





3

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##### Scientific Literature and Risk Assessment

A targeted literature review and risk characterization process were implemented to establish toxicological relevance and support evidence-based conclusions.





4

![Challenge]()

##### Regulatory-Ready Report Development

Freyr developed comprehensive assessment reports containing scientific rationale, safety evaluations, risk conclusions, and supporting documentation suitable for regulatory submission and review.











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## Impact



Freyr transformed an urgent toxicological assessment requirement into a structured, science-driven evaluation process, enabling the client to make informed regulatory decisions without delaying project timelines.



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##### Faster Delivery

- Complete Toxicological Risk Assessment delivered within 48 hours
- Accelerated regulatory decision-making timelines
- Rapid response to critical product safety questions





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##### Scientific Excellence 

- Comprehensive evaluation of identified leachables and impurities
- Robust toxicological risk characterization completed
- Evidence-based conclusions supported by scientific literature





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##### Regulatory Readiness 

- Regulatory-ready assessment reports delivered
- Enhanced confidence in product safety evaluation
- Improved readiness for regulatory interactions and submissions





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##### Operational Efficiency 

- Reduced burden on internal scientific and regulatory teams
- Enabled focus on broader product development priorities
- Supported timely progression of regulatory activities