Animal Testing
We can offer advice and practical assistance in following areas of animal testing services:
- Identification of needs for animal testing to market drug products in India as per New Clinical Trail Rules, 2019 and other region specific regulations
- Placing and monitoring of animal studies for active pharmaceutical ingredients (APIs) and impurities with third party laboratories (through a network of affiliated CROs)
- Protocol design, study samples requirements calculation, review of study protocols and final reports for toxicology studies
- Study management, GLP compliance and animal welfare monitoring and ensuring conduct of toxicity studies in stipulated timelines
- Compilation of animal testing data in SEND (Standard for Exchange of Nonclinical Data) data standardization format as per US FDA requirements (if needed)
