Our experts can review and advise on the status and sufficiency of your non-clinical data dossier for further development, as well as assist in the design and procurement of necessary or recommended elements, including: 

  • Recommended in vitro experiments and in vivo animal models 
  • Academic and pre-clinical research organization site selection and auditing 
  • Protocol Development – Toxicology/Pharmacology/ADME 
  • Study Monitoring – Toxicology/Pharmacology/ADME 
  • Pre-clinical report generation, revisions and review 
  • Non-clinical module preparation for submissions from IND to NDA/BLA