Aurigene Pharmaceutical Services offers a full range of exploratory and GLP toxicology studies supported by clinical and anatomic pathology services, formulation analysis, toxicokinetic analysis, and interpretation and reporting. General toxicology studies range from single-dose and repeat dose toxicology studies, genetic toxicology, and IND and NDA enabling safety toxicology package. We have a track record of successfully filing IND’s using the in-house data with the US FDA, MHRA, EMEA and DCGI and ANDAs with US FDA.
The toxicology services team has experienced and qualified scientists with DABTs and DIBTP certified pathologists. Central to our ability to deliver world-class toxicology services to our global clients from our state-of-the-art vivarium for conducting toxicology studies in rodents. Our facility is GLP certified since 2003 and has sufficient capacity to undertake genetic and GLP toxicology studies.
Our labs are access controlled and spread over 18,040 square feet. The rodent animal facility is a double corridor facility with dedicated experimental rooms equipped with Individually Ventilated Cages (IVC). This animal facility is registered under the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), India. Our toxicology facility has been inspected by US FDA and National GLP Compliance Monitoring Authority (NGCMA). Our stringent data management is GLP compliant and periodically backed up and the systems and processes are rigorously monitored by an independent Quality Assurance unit (QAU).
Aurigene Pharmaceutical Services has proven experience to carry out a range of toxicology services to provide seamless integration between discovery and development programs.
Our GLP facility is specialized in the development of bioanalytical methods to support bioavailability and pharmacokinetics studies. The services include:
Our state-of-the-art facility helps us provide a broad-based analysis of a variety of parameters in each of the following categories: