Our Team of consultants helps our clients develop clinical testing plans consistent with the stage of preclinical development and FDA requirements. during the in vitro to in vivo studies, our preclinical toxicology team can provide the expertise ,helps to cover all aspects of the preclinical phase of development for drugs, medical devices and other health care products. We identify the key preclinical safety issues, and devise a testing plan to address them in the most cost-effective approach.
Preclinical safety assessment
- Our team performs Literature review and technology assessment
- Review of existing preclinical safety testing plan and relevant data
We perform Full study design of safety pharmacology, ADME/ pharmacokinetic and repeat-dose toxicology studies - Toxic risk assessment for human exposure and clinical trials
- Preclinical toxicology assessments
- Phase 1 protocol development, including safety monitoring
- Investigational Medicinal Product Dossier (IMPD)
- Nonclinical sections of CTD
- GLP study report writing