Toxicology studies

This service provides comprehensive toxicology studies to support the non-clinical development of healthcare products, including advanced therapies and chemical-based innovations. It covers a broad range of toxicological assessments such as acute, subacute, subchronic, and chronic in vivo toxicity, as well as reproductive and developmental toxicity, local tolerance, mutagenicity, and genotoxicity studies. In addition, the service includes tailored advisory support to define an appropriate toxicology roadmap aligned with the product profile and applicable regulatory requirements. The service is designed for EIC beneficiaries including public research organisations (universities and research institutes) and private sector entities (biotechnology and pharmaceutical companies) developing health-related products. It supports both exploratory non-Good Laboratory Practice (non-GLP) studies and fully compliant GLP toxicological studies required for product development and regulatory submissions. The duration of the service varies depending on the scope, study design, and regulatory strategy, ranging from short-term in vitro assessments to longer-term in vivo studies. The engagement begins with a protocol development phase, during which the study design is defined in close collaboration with the beneficiary. This is followed by study execution, data analysis, and the preparation of a final report. For GLP studies, all phases, including protocolisation, execution, analysis, and reporting, are conducted under strict quality control and audited in compliance with GLP requirements. All studies are performed under ISO 9001:2015-certified quality management systems, with GLP compliance applied where required. The service is delivered by in-house scientific teams, supported by internal auditors and regulatory experts to ensure high-quality outputs and adherence to international standards. As a result, beneficiaries receive a comprehensive final study report suitable for internal decision-making and/or regulatory use, enabling informed progression of their product development pipeline.