Comprehensive Toxicology Expertise
At ERBC, we provide a full range of regulatory and investigative toxicology services to assess the safety of pharmaceuticals, chemicals, agrochemicals, cosmetics, and medical devices, ensuring compliance with international standards.
Reliable and Predictive Assessments
Our studies, conducted under GLP and non-GLP conditions, offer robust and translational insights to support risk assessment and informed decision-making throughout product development.
Tailored Approaches for Every Need
With scientific expertise and regulatory guidance, we adapt our toxicology programs to meet specific project requirements, integrating innovative models and New Alternative Methodologies (NAMs) for a more ethical and predictive evaluation.
Cardiotoxicity
Cardiac adverse events are the leading cause of discontinuation of clinical trials and account for almost 25% of all drug withdrawals from the market in the US. Cardiotoxicity encompasses a number of conditions that cause damage to the heart muscle and include cardiac dysfunction, heart failure, myocardial ischemia, valvular abnormalities, pericardial disease, hypertension, and arrhythmias. Today, cardiac toxicity has become a major concern in the development of new cancer treatments given that a number of targeted therapies and next-generation cell- and antibody-based immunotherapies have been shown to affect the cardiovascular system.
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In-vitro toxicology
In vitro toxicology has progressed hugely over the past decades and is now seen as a science in itself. In line with the 3Rs concept, ERBC performs ICH and OECD compliant tests to identify toxicology events in nonwhole animal models (cell cultures, 3D models…).
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Genetic toxicology
Genetic toxicology aims to determine whether or not a given compound will induce mutations or chromosomal damage in humans. Today, new insights into the mechanisms of mutagenicity has opened up new possibilities for testing and predicting mutagenicity.
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Local tolerance
Non-clinical local tolerance testing is intended to support human exposure to a compound (both active substance and excipients) at contact sites of the body. Local tolerance testing should be conducted initially in support of clinical trials, but also later on to support a final product.
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General toxicology
ERBC provides GLP-compliant general toxicology studies, delivering reliable safety assessments through systemic, repeated-dose, and organ-specific toxicity evaluations tailored to regulatory requirements.
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Carcinogenicity
Regulators around the world require carcinogenicity studies for new therapies intended for long-term use, for chemicals expected to have prolonged human exposure and for any compound showing a carcinogenic potential. These studies are generally performed during clinical development or before marketing authorization or in some cases post approval (for drugs intended for the treatment of patients with limited options or with clearly demonstrable added value).
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Developmental and reproductive toxicology
Pharmaceuticals and chemicals have sometimes unanticipated and complex impacts on reproductive capacity and/or embryonic development: they can affect sexual function and fertility in adult males and females or lead to malformations, developmental retardations or mortality of the fetus when pregnant women are exposed. Over the past 30 years, fundamental understanding of embryogenesis and mechanisms of developmental toxicity have greatly advanced as well as the regulatory framework of the developmental and reproductive toxicology (DART) studies.
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Juvenile toxicology
The Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) enacted in the US in 2002 and 2003, respectively, and later mirrored in Europe, have driven a significant increase in the number of drugs with pediatric labeling and a growing interest in juvenile toxicology. This field of study presents many challenges, the first being that children are not small adults, but instead individuals going through multiple life stages, from neonatal, to early and late infantile, juvenile, and peripubertal stage.
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Immunotoxicology
Toxicity to the immune system encompasses a variety of adverse events, including the ability of a compound to override the immune system and cause an allergic reaction, or to impair the immune functions required by the host to defend itself against infectious or neoplastic disease. To comply with regulatory authorities, all new human pharmaceuticals and chemicals need to be evaluated for their potential to produce immunotoxicity.
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