Developmental & Reproductive Toxicology
Chemicals and pharmaceuticals can have unanticipated and complex impacts on prenatal and postnatal development and reproductive capacity. How can you be confident that your product is safe for sensitive subpopulations such as pregnant women and children? Battelle can provide the answers you need for regulatory approval, risk reduction and product safety decisions.
We conduct Developmental and Reproductive (DART) studies for a broad range of chemicals and pharmaceuticals. Our studies are used for:
- Required preclinical studies for FDA approval of new drug and biologic therapies
- Product registration for agrichemicals
- Evaluation of the developmental and reproductive effects of industrial chemicals and environmental toxins
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The Battelle DART team brings together experts in developmental, reproductive, and endocrine toxicology with board-certified pathologists, general toxicologists, neurotoxicologists, and inhalation toxicologists and engineers for an integrated approach to toxicology. Battelle has more than 30 years of experience in conducting GLP-compliant toxicology studies for drug approval, product registration and product safety/efficacy. Our DART services are backed by decades of experience in pre-clinical research, industrial toxicology and environmental toxin studies. We can fulfill all of your study needs for FDA approval, OECD approval or EPA regulatory requirements.
A full battery of DART studies including fertility, developmental toxicity, juvenile toxicity studies and single and multigenerational reproduction studies
DART studies conducted under FDA, EPA, OECD and international guidelines to ensure accurate, reliable and defensible results
Broad toxicology capabilities including general, inhalation, cardiovascular, pulmonary and neurobehavioral for combination and add-on studies
Our DART capabilities include small molecules, biopharmaceuticals, vaccines, industrial chemicals, agrochemicals, and hazardous chemical and biological agents. We offer:
Embryo-fetal developmental toxicity
Male and female fertility
Combined fertility and developmental toxicity
Pre- and post-natal development
One- and two-generation reproduction
Extended one-generation reproduction
At Battelle, we don’t just conduct studies—we solve problems. We go beyond standardized study designs to understand the specific questions you need to answer and the potential challenges that could arise. Our experts can help you cut through the complexity of DART study design and develop a program that meets your needs both technically and strategically.
Above all, we are committed to quality in study design and execution. Our approach ensures that you will get the answers your need the first time, so you can proceed to regulatory submission with confidence.