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Nonclinical

Our experts can review and advise on the sufficiency of your non-clinical data dossier for further development.

They can assist in the design and procurement of necessary or recommended elements.

Services include:

  • In vitro experiments and in vivo animal models  
  • Academic and pre-clinical research organization site selection and auditing  
  • Protocol development and study monitoring (toxicology, pharmacology, and ADME) 
  • Pre-clinical report generation, revisions, and review  
  • Non-clinical module preparation for regulatory submissions (e.g. IND, NDA, or BLA)