Eurofins Advinus provides services in performance of Developmental and Reproductive Toxicology (DART) for the progression of pharmaceuticals and biopharmaceuticals.
We conduct male and female fertility (Segment I), embryo fetal (prenatal) developmental toxicity (Segment II) and pre & postnatal development (PPND) (Segment III) studies to assess the potential effects of a test substance on the full spectrum of reproduction as well as perform a range of specialized functional evaluations, including neurobehavioral testing, hormonal and immunologic assays as per ICH and other regulatory guideline requirements.
Our staff has more than 20 years of experience and expertise in this field. We have completed over 170 male/female fertility/perinatal/repro screening/multi-generation studies and 50 rabbit Segment II studies (till date) by oral and parenteral routes of administration.
Why Partner with Eurofins Advinus -
- Capacity: 20 repro studies/year of various types (male/female/perinatal/repro screening/multi-generation studies) and 20 rat/mice and 10 rabbit embryo fetal (prenatal) developmental toxicity studies per year
- Fresh soft tissue evaluation for visceral organ anomalies in embryo fetal (prenatal) developmental toxicity studies
- On-line data capture using Provantis software
- Extensive in-house developed historical data for reference
- In-house GLP bioanalytical and formulation support
- Data submitted to US FDA, EMA and other regulatory agencies across the world