IND-Enabling Studies

IITRI has extensive experience evaluating the safety of small molecule drugs and biologics to support IND/NDA submissions of new drug candidates including repeat-dose studies in rats and dogs, genetic toxicology studies and nonclinical safety pharmacology. In addition, our on-site bioanalytical laboratory provides a full range of analytical services to support GLP requirements of preclinical drug development.

We offer a collaborative approach that includes:

  • Preclinical advisory with study design guidance, IND program optimization and pre-IND meeting support
  • Coordination with formulation CROs on programs to optimize bioavailability or minimize immunogenicity
  • Open lines of direct communication with Study Directors for a seamless study team approach from start to finish

The IITRI team excels at interfacing with small to mid-size biopharma to navigate and execute a program of preclinical safety and toxicology studies necessary for IND submission.