Business Imperatives

  • A leading global pharmaceutical company specializing in veterinary products, approached Freyr for Toxicological Risk Assessment (TRA) reports, including PDE assessment, as part of their goal to launch a drug-device combination product.
  • The client sought Freyr's support due to a lack of literature on the detected impurities and insufficient in-house capabilities for quantification.  

Objectives

To quantify impurities for a drug-device combination and conduct Toxicological Risk Assessment (TRA) reports with PDE assessment, all tailored for veterinary use within the Australian region.

Problem Statement

  • Client faced hindrances in Regulatory processes due to leachable traces in the product. 
  • The client was unable to quantify the impurities. 
  • Lack of literature around impurities detected. 
  • Client expected quick action to fulfill Regulatory formalities.  
  • Lack of in-house competencies for quantification. 

Freyr Solutions and Services

Freyr Solutions and Services
  • Freyr experts measured and evaluated over 25 impurities, ensuring they met the required threshold. 
  • An additional PDE report was provided by the SME team. 
  • Promptly delivered a comprehensive solution within 48 hours. 
  • Gather Data: Collected all the relevant data on the substance, including chemical properties, toxicity data from animal studies, human clinical data (if available), exposure data, and any relevant Regulatory guidelines or standards. 
  • Hazard Identification: Evaluated the available data to identify the potential hazards associated with the substance. 
  • Exposure Assessment: Estimate the levels of exposure to the substance for the target population through various routes, such as ingestion, inhalation, and dermal contact.  
  • PDE Determination: Establish a Permitted Daily Exposure (PDE) for the substance based on relevant Regulatory guidelines or industry standards.  
  • Risk Management: Based on the risk characterization results, identified, and evaluated potential risk management strategies to mitigate any identified hazards or exposures.  
  • Peer Review and Regulatory Submission: A peer review of the TRA report by qualified experts to ensure its scientific validity and reliability was done.  
  • Monitor and Review: Monitored any emerging hazards or changes in exposure patterns that may impact the risk assessment conclusions. 
  • First-of-kind TRA project with a successful outcome. 
  • Quick TAT within 48 hours. 
  • Provided client with PDE reports as additional deliverables. 
  • Successfully quantified impurities for a drug-device combination.
  • Completed Toxicological Risk Assessment (TRA) reports with PDE assessment for a drug-device combination.