Protocol, Final Report and other Areas of the GLP Compliance 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) standards. We also provide support on process and facility inspections, as well as … Read more
Agrochemicals Compliance with REACH Regulation We offer support for meeting REACH regulation from a technical and toxicological perspective by evaluating the available information and/or defining the toxicological studies required for this regulation. Expert Opinions in Toxicology Our technical staff can issue expert opinions in toxicology by conducting a case-by-case risk assessment. These opinions will be … Read more
Nonclinical Development Programs We prepare nonclinical programs tailored to the specific needs of your pharmaceutical or immunological veterinary products under development. We understand that every test substance has unique pharmacological properties and toxic class alerts and falls under the scope of different regulatory framework with regards to its chemical nature, origin or clinical indication. The … Read more
Safety Assessment of Cosmetic Products 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 the case that available information … Read more
Biological Evaluation of Medical Devices according to ISO 10993 Standards We perform 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 … Read more
Design of Nonclinical Development Programs 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 falls under the scope of different regulatory frameworks with regards to its chemical nature, origin or clinical indication.Strategic and financial circumstances … Read more