From conduct of nonclinical studies ro preparation of IB and PMDA Consultation Materials
- Central management of nonclinical studies(outsourced monitoring)
- Troubleshooting for nonclinical studies(judgment of necessity of additional studies and study designs)
- Preparation of nonclinical parts of IB and PMDA consultation materials inJapanese
- Consulting of assessment of toxicity and pharmacokinetic studiesm go/no-go decision on drug development and PMDA consultation
Clinical Study Support
Cooperation with a clinical development CRO such as PPD-SNBL