Full-stack IND-enabling Toxicity Studies to assess safety profile of new drugsFor a molecule to progress smoothly from early-stage discovery to the investigational new drug (IND) phase and further to successful clinical trials, the data from preclinical trials must be accurate, reliable, and based on the best suitable and comparable models available to the target population. This means the IND or drug product must undergo a series of robust tests and experiments as per the focused indication and regulatory guidelines (FDA/EMA etc.). Syngene’s safety assessment and toxicology services team offers a full range of exploratory, GLP toxicology studies and specialty studies that enable clients to assess a new drug’s safety and toxicity profile. Our offerings are supported by clinical and anatomic pathology services, formulation analysis, toxicokinetic analysis, interpretation, and reporting services. We deliver high-quality reports, including providing a secure portal for electronic data transfer while maintaining industry-leading turnaround times.
Association memberships and accreditations
*Association for Assessment and Accreditation of Laboratory Animal Care | CCSEA: Committee for the Control and Supervision of Experiments on Animals | GLP: Good laboratory practice | IAEC: Institute Animal Ethics Committee | IBSC: Institutional Bio-Safety Committee