The SAXOCON team can help you understand what your regulatory obligations are and provide advice on the strategical aspects of planning the market authorization in order to achieve regulatory compliance.
- Human health hazards
Assessment of the possible health hazards of the biocidal active substance or product for all required toxicological endpoints and in accordance with current data requirements.
- Human exposure assessment
The human exposure assessment can vary significantly depending on the product type and market application. The SAXOCON team includes toxicologists who are specialized in the human exposure of biocidal products, and who are experienced users of the current exposure scenarios and computational tools.
- Study management
Should further toxicological testing be needed, SAXOCON can offer guidance in the selection of test laboratories, methodologies employed and other test parameters. We are also able to act as the Sponsor Representative or Study Monitor.
The issue of purity is increasing for biocidal active substance assessments. Consequently, the use of computational toxicology is essential to assess the mutagenicity of impurities. These in-silico tools can also be applied to the application of technical equivalence for the inclusion of a chemical source to the Article 95 list.