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Our Services >> Extractables & Leachables >> Toxicological Evaluation and Consulting

Toxicological risk assessment

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Exposure to extractables or substance chemicals residue can compromise patients safety. Identifying and limiting the risks associated with hazardous materials is imperative to comply with regulatory requirements accross the pharmaceutical and medical devices industry.

A toxicological risk assessment is the overall goal of conducting extractables and leachables studies. A toxicological risk assessment must be performed by a qualified toxicologist on all leachables found in the final drug product at concentrations above the AET. In the case where there is insufficient literature data, studies must be conducted in order to complete the risk assessment.

We have the capability to evaluate compounds by referring to both toxicological databases and QSAR methods. We are experienced in performing toxicological analyses on medical devices, including dental and gas pathway devices, as well as pharmaceutical container/closure systems according to standards such as ISO 10993-17 and ISO 18562 and guidance documents from the FDA and PQRI.

Our dedicated expert team of 40+ toxicologists and consultants at Eurofins Regulatory & Consultancy Services Italy, with board-certified team, including one European Registered Toxicologists (ERT) and one HAS Consultant, will provide top-tier services services to meet global regulatory compliance. Our one-stop-shop solution holistic approach will address client's needs with optimal use of resources, while ensuring project timelines are consistently met.

Discover our full range of services for drug products, biologics and medical devices.

Toxicological risk assessment for drug products and biologics

  • E&L validation planImplementation of the optimal regulatory strategy based upon the specific drug product and drug substance
  • Data gap analysis and quality review:
    Evaluation of already generated extractable and leachables data and their application to a specific drug product and drug manufacturing process
  • Change assessment for the evaluation of E&L related  impact within the manufacturing process and primary packaging
  • Risk assessment for a risk-based approach to E&L testing strategy:
    Risk  level definition for each process components and primary packaging as well as an appropriate risk mitigation strategy
  • Toxicological risk assessment on the compound of potential concern identified in the E&L studies:
    Performed by expert toxicologist (including ERT)
  • Permitted daily exposure to evaluate toxicological profile of compounds
    Includes expert review relevant data and scientific literature, use of In silico methods, QSAR and read-across
  • Evaluation of process related impurities and special impurities such as Nitrosamines
  • Technical support of our consultant in the interaction with Regulatory agencies and to reply to deficiencies  
  • Extended experience in project management to help clients navigate into the complexity of an E&L study

Toxicological risk assessment for medical devices

  • Biological Risk Assessment (for all medical device Risk Class, including for combination products)
  • Chemical characterization Plans e AET calculation
  • Toxicological Risk Assessment (raw material, Extractables and Leachables)
  • Assessment on the absorption profile of a substance-based medical device
  • Change Management
  • Regulatory issues (NB or FDA non-conformity) and Management of unexpected data
  • Gap analysis
  • Packaging Validation
  • Clinical Support and Usability
  • Clinical Evaluation Plan
  • Literature Review, data identification and data appraisal, medical writing
  • Clinical Evaluation Report revision or support in filing Clinical Evaluation Report
  • Usability assessment
  • Usability testings
  • Technical Documentation compilation
  • Risk Assessment ISO 14971
  • Quality Management System ISO 13485
  • Classification of medical devices according to MDR
  • Literature review supporting equivalence, claims and mechanism of action
  • Screening for Pharmacological/ Metabolical/ Immunological mechanism Post Market Support
  • PMS Reports
  • PMCF Plans
  • PMCF Reports
  • PSUR
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