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Toxicological Risk Assessments (TRAs) are essential components of product development, manufacturing, and post-marketing surveillance. TRAs are to be performed by qualified and experienced toxicologist, that have knowledge of the latest regulatory expectations (i.e., (V)ICH, FDA, EMA, ISO, …).
On the one hand it is required that safe levels are established for cross-product contamination, extractables and leachables (E&L), mutagenic and non-mutagenic impurities, particle contamination, and volatile organic compounds.
On the other hand, excipients, degradants, contaminants, and residual solvents should be controlled at levels that are scientifically justified and supported.
Hazard assessments include a comprehensive literature search in a wide variety of toxicological databases. When the available data are insufficient, (quantitative) structure-activity relationship ((Q)SAR) tools (i.e. in silico tools) and/or read-across approaches (i.e. data available for structurally and toxicologically similar chemicals) can be applied to fill data gaps.
Additional testing is only recommended when it is absolutely necessary. We have expertise for following types of qualitative/quantitative hazard assessments:
For each type of product a dossier needs to be compiled. This dossier is to be submitted to a regulatory authority for review, and approval of the submission would grant the product access to the market. We can assist with scientific writing of non-clinical sections in regulatory documents and/or registration dossiers such as:
Other services include:
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