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)