Development & Reproductive Toxicology (DART)
Adgyl Lifesciences offers DART studies performed by a team of well experienced scientists in accordance with current OECD, US FDA, ICH, EMA and DCGI guidelines. The test facility has extensive background control, and the study data is captured and reported using Provantis data collection system.
Overview of Development & Reproductive Toxicology (DART) studies
We provide a full range of DART studies in compliance with ICH S5 (R3), ICH S11, and New Drugs and Clinical Trial rules (NDCT), 2019 (DCGI) guidelines. Our portfolio includes fertility and early embryonic development, embryo‑fetal developmental (preliminary and definitive), pre‑ and postnatal development, juvenile toxicity, male and female fertility, teratogenicity, and perinatal studies conducted in appropriate rodent and rabbit species.
Key Services Include
Fertility and Early Embryonic Development (FEED) study in mice/rats
Preliminary Embryo-Fetal Developmental (pEFD) toxicity study in mice/rats/rabbits
Definitive Embryo-Fetal Developmental (EFD) toxicity study in mice/rats/rabbits
Pre and Postnatal Developmental (PPND) toxicity study in mice/rats
Juvenile toxicity studies in mice/rats
Male/female fertility study in mice/rats
Prenatal Developmental Toxicity (PNDT) study in mice/rats/rabbits
Perinatal study in mice/rats
Scientific Partnership
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible and timely study execution.
High‑quality data generation aligned with scientific & regulatory requirements
Seamless end‑to‑end support spanning study design, execution, and data interpretation.
Connect with our expert team today to discuss how we can support your development and reproductive toxicology study requirements.
what people ask
Frequently Asked Questions
Are your DART studies compliant with global regulatory guidelines?
Yes. All DART studies are conducted in accordance with current OECD, US FDA, ICH, EMA, and DCGI (India) guidelines, including ICH S5 (R3), and ICH S11
Which species are used for DART studies?
We conduct DART studies in mice, rats, and rabbits, as appropriate for the study design and regulatory requirements.
Do you conduct juvenile toxicity studies?
Yes. We offer juvenile toxicity studies in mice and rats in accordance with ICH S11 guidelines to support pediatric development programs.
How is study data captured and reported?
All study data are captured, managed, and reported using the Provantis data collection system to ensure data integrity, traceability, and regulatory compliance.
Can your DART studies support global regulatory submissions?
Yes. Our DART study designs and reports are aligned with global regulatory expectations and can support IND, NDA, and other regulatory submissions worldwide.
