We prepare nonclinical programs tailored to the specific needs of your compounds under development. We understand that every test substance has unique pharmacological properties and toxic class alerts and is under scope of different regulatory framework with regards to its chemical nature, origin or clinical indication.

Strategic and financial circumstances of each sponsor are also unique. It is for all this, we think that every nonclinical program is different and needs to be adjusted to particular situations.

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Categorization of medical devices to select the appropriate nonclinical tests to perform, taking into account the type, degree and duration of contact of the medical device with the body, as well as the toxicological profile of the substances present in the final product and the amount of such substances that can be available to the human body.

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We support our client on the safety assessment of cosmetic products in accordance with the requirements of the cosmetic directive and regulation in force.

The safety assessment will be based on available peer-reviewed toxicology literature, MSDSs, trade association documents, and governmental listings and databases. In case that not sufficient information is available from these sources, and if experimental evidence is required, we would place studies, and monitor CROs capable of carrying out in vitro toxicology studies in accordance with appropriate guidelines.

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We prepare nonclinical programs tailored to the specific needs of your pharmaceutical and immunological veterinary products under development. We understand that every test substance has unique pharmacological properties and toxic class alerts and is under scope of different regulatory framework with regards to its chemical nature, origin or clinical indication.

Strategic and financial circumstances of each sponsor are also unique.

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We offer support for meeting REACH regulation from a technical and toxicological perspective evaluating the available information and/or defining the toxicological studies claimed for this regulation.

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Acting as monitoring scientist we verify the GLP compliance of the main documents in a GLP study such as protocol and final report according to OECD  (ENV/MC/CHEM(98)17) and FDA (21 CFR 58) standard. We could also provide support on the process and facility inspections as well as on raw data and SOP verification in the studies we are involved in.

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