TOXICOLOGICAL-RISK-ASSESSMENT-AS-A-SERVICE

Any chemical can be harmful to the human body (hazardous) when the dose (exposure) is sufficiently high. Certain components of a pharmaceutical or medical device, cosmetic ingredient, consumer product, or food ingredient may be suspected as hazardous and must be qualified to ensure safety of patients and/or consumers. We help you to identify potential risks of your product from scratch.

To achieve this, we fully review the data existing in the literature by way of a comprehensive literature search that covers a wide variety of medical and toxicological databases. If data gaps have been identified, we apply quantitative structure-activity (QSAR) tools (also called in silico tools) or read-across approach from available data of structurally and pharmacologically similar chemicals.

If necessary, we recommend new experiments. It is essential that these studies are designed appropriately, conducted to the highest standards, and reported with clarity, in the required timelines. An independent Study Monitor helps to select the right CRO and ensures delivery of a high-quality data that meets the needs of the project.

All throughout the process, we keep the regulatory expectations in mind so that the assessment reports are accepted in the first place without having to answer follow-up regulatory queries.