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.
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.
Services in Scope
Toxicological Risk Assessment (TRA) for a Drug-Device
Combination Product
Leachables and Impurity Evaluation
Toxicological Data Review and Scientific Literature Assessment
Risk Characterization and Safety Evaluation
Regulatory Medical Writing and Report Preparation
Rapid Turnaround Scientific Support
Challenge
Urgent Assessment TimelinesThe client required a complete toxicological evaluation within an extremely short timeframe to support ongoing regulatory activities.
Leachable Trace IdentificationDetected leachable compounds required rapid toxicological evaluation and safety characterization.
Limited Time for Literature Review Comprehensive scientific evidence needed to be sourced, evaluated, and incorporated within a compressed project schedule.
Regulatory Documentation ReadinessThe final assessment required scientifically robust documentation suitable for regulatory review and decision-making.
Solution
1
Rapid Project Mobilization
Freyr assembled a multidisciplinary toxicology and medical writing team to initiate the assessment immediately and support accelerated delivery timelines.
2
Comprehensive Toxicological Evaluation
Experts conducted detailed reviews of available toxicological data, impurity profiles, exposure assessments, and safety thresholds for identified leachables.
3
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
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.
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.
Faster Delivery
- Complete Toxicological Risk Assessment delivered within 48 hours
- Accelerated regulatory decision-making timelines
- Rapid response to critical product safety questions
Scientific Excellence
- Comprehensive evaluation of identified leachables and impurities
- Robust toxicological risk characterization completed
- Evidence-based conclusions supported by scientific literature
Regulatory Readiness
- Regulatory-ready assessment reports delivered
- Enhanced confidence in product safety evaluation
- Improved readiness for regulatory interactions and submissions
Operational Efficiency
- Reduced burden on internal scientific and regulatory teams
- Enabled focus on broader product development priorities
- Supported timely progression of regulatory activities
