Nonclinical

Nonclinical

Kinexum experts can review your nonclinical dossier, including both in vitro and in vivo (i.e. animal model) studies. We can help you design and procure necessary and recommended elements.

Our services include:

  • Review of documentation and gap analysis
  • Toxicology, pharmacology, and ADME study design and monitoring
  • Academic and CRO site selection and auditing 
  • Preclinical report generation, revision, and review
  • Nonclinical module preparation for regulatory submissions (e.g. IND, NDA, BLA, PMA)