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
