Regulatory Toxicological Services and Risk Assessment

Chemicals have the potential to harm the human body, but the level of risk depends on the amount of exposure. Toxicological risk assessment is crucial in evaluating the safety of chemicals in relation to human exposure.The purpose of toxicological services and risk assessment is to analyze available data on the potential hazards of a chemical and compare it to the expected exposure levels. This helps determine the likelihood of harm occurring. Regulatory bodies rely on this information to make informed decisions and ensure patient safety.

Qualified and experienced toxicologists play a vital role in performing these assessments. They have the expertise to assess the risks associated with different chemicals and provide valuable insights for regulatory compliance. At BIOTOX LABORATORIES, our team of ERT-registered toxicologists specializes in hazard identification, risk assessment, exposure assessment, and toxicological profile development for chemical ingredients. We ensure thorough assessments for product safety, providing reliable toxicological expertise that complies with regulatory requirements.If you need assistance with toxicological services and risk assessment, our team of specialists is here to help. We can create a customized service plan tailored to your specific needs and provide the expertise required to navigate the complex world of chemical safety.Feel free to contact us to discuss how we can assist you in ensuring the safety of your products or operations. Together, we can make informed decisions and protect human health.

  • Biocompatibility risk assessment
  • Biocompatibility evaluation plan
  • Biocompatibility evaluation report
  • Designing of biocompatibility studies as per ISO 10993 and ISO 18562
  • Nitrosamine risk assessment and derivation of acceptable intake
  • Toxicological Expert Statement for impurity specification
  • Risk benefit evaluation of active ingredients for the intended patient population, route and dosage form
  • Genotoxicity evaluation using in silico QSAR tools
  • ICH M7 hazard assessment and qualification
  • Qualification of impurities using existing data (for small molecule/peptides/proteins/vaccines)
  • Excipient evaluation and justification for the proposed limit
  • Extractable and Leachable (E&L) risk assessment
  • Evaluation of cosmetic ingredients/products and derivation of margin of safety
  • Assessment of fragrances and flavours
  • Qualification of impurities
  • Permitted Daily Exposure (PDE) or Acceptable Daily Intake (ADE) in support cleaning validation (APIs and cleaning agents)
  • Occupational Exposure Banding (OEB)/Occupational Health Categorisation (OHC) for drug substance intermediates and starting materials
  • Occupational Exposure Limit (OEL)
  • Food contact materials/food additive evaluation
  • Toxicological evaluation of consumer products/ingredients, including hand sanitisers and antiseptics
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