Determine if your container, closure, device or material is suitable for use through an evaluation of toxicological impact. We offer toxicological risk assessment (TRA) services to evaluate risks to patient health by assessing the leachates of a system against information on in vitro tests, animal studies, computational methods and predictive means. This information allows you to mitigate risk during product development and demonstrate safety in regulatory documentation.

Our complete suite of TRA services includes:

  • Estimation of risk from extractables and leachables compounds from container, closure and drug delivery systems
  • Determination of PDEs, ADIs and margins of safety from process impurities, residual solvents, degradants and other source materials
  • Packaging compliance guidance and product labeling reviews
  • Determination of biocompatibility and/or suitability
  • Assessment of material vendor, supplier and manufacturer changes (change control)
  • Consideration of potential for misuse of the product (failure analysis)
  • Additional testing if necessary to determine risk of chemical profile

Contact our analytical testing team by clicking below

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