One of toxconsult´s commitments is to assist its clients during the whole development process of new molecules in the entire safety study program and in international registration.
We support you regarding all relevant laws, guidelines and required guidance documents for the product safety worldwide. In addition we prepare development programs, study designs and protocols, assist you in searching and contacting potential CRO´s if requested, and support you in conducting studies, reports, evaluations as well as in data interpretation. toxconsult provides data reviews of available information in the context of the whole toxicological profile and also of other existing data, like from toxicokinetics and metabolism. Furthermore we offer constructive analysis of study results, regarding further development and possible issues for further development and registration, as well as support in potential solution proposals. If requested we take over the reporting and editing of technical reports, take care of quality checks/QC, GLP checks and the finalization of reports for the submission to agencies. Other toxconsult services are project coordination and consultation in areas which have to be coordinated with other fields relevant for registration like pharmacokinetics, metabolism, analytical chemistry and formulation technology. To perfect our services we assist you in carrying out the bridging of toxicological properties of new formulations or combinations of active ingredients.
- Guideline support (EU, EPA, FDA, ICH, VICH etc.)
- Evaluation & interpretation of data
- Data reviewing
- Constructive analysis
- Reporting and editing
- Project coordination and consultation
- Testing and ‘bridging’
