Safety Assessment

Safety Assessment and Toxicology Services
Syngene Safety Assessment team offers a full range of exploratory and GLP toxicology services supported by clinical and anatomic pathology services, formulation analysis, toxicokinetic analysis, interpretation and reporting. General toxicology studies range from single-dose/ repeat-dose toxicology studies, genetic toxicology, juvenile toxicity to IND and NDA enabling safety toxicology packages. Syngene also offers standalone histopathology and peer review services to companies through our certified and experienced pathologists

Central to our ability to deliver world-class toxicology services to our global clients is our state-of-the-art vivarium. AAALAC accredited and GLP certified since 2009, the facility is equipped to undertake the toxicology studies mentioned above. Our streamlined workflows, processes, and robust communication systems ensure high quality, timely communication across time zones as well as secure data transfer to our clients from around the globe while maintaining industry-leading turnaround timelines.

What makes us different?

  • Experienced and qualified scientists with 8 DABTs and 1 ACVP certified pathologist
  • High-quality reports and class-leading TATs
  • Expertise and capability to handle diverse routes of administration ranging from oral, IM, SC, interdermal, inhalation, intravitreal injection to complex intravenous infusion studies
  • Tenured study directors and low attrition ensures continuous, high-quality client support
  • Proprietary histopathology software (Spectral Insights) for sharing electronic images with the client pathologists for the immediate review of the key findings
  • Online preclinical data capture software and data submission to FDA in SEND format (Pristima and Savante from Xybion Corporation)
  • Secure portal for electronic data transfer

NonGLP 14-Day Toxicity Study: Timelines (Example)
Approx. 30-40 tissues/animal (n=6/sex/group)

GLP 28-Day Toxicity Study: Timelines (Example)
Approx. 40 tissues/animal (n=10/sex/main tox group)

GLP 90-Day Toxicity Study: Timelines
Approx. 40 tissues/animal (n=10/sex/main tox group)

IND GLP tox and safety pharmacology: Timelines (Example)