- Services
- Non-clinical consultation/Clinical consultation
Non-clinical consultation
- Non-clinical due diligence assessment
- Non-clinical data assessment
- Non-clinical study plan advisory
- Advisory on Non-clinical study strategy for NDA based on guidelines
- CLO selection and GLP audit advisory
- Non-clinical study protocol support
- Non-clinical study report support
- Support for regulatory consultation with PMDA
- Preparation of NDA submission and CTD
- Support with Compliance Inspection of Non-clinical documents
- Assistance for PMDA pre-assessment consultation
- Support with PMDA communication (response to questions) after NDA submission
- Assistance for CTD revision for the drug committee
- Review report and CTD masking assessment
- Advisory on Non-clinical development strategy plan for life cycle management
Clinical consultation
- Clinical due diligence assessment
- Clinical data assessment
- Clinical study plan advisory
- Advisory on clinical study strategy for NDA,including PMDA consultation
- PMDA regulatory consultation support
- Clinical study protocols assistance
- Clinical study management and implementation assistance
- Clinical study data management advice
- CRO selection and GLP audit advisory
- Clinical study report assistance
- Clinical trial notification assistance
- PMDA pre-assessment consultation assistance
- Preparation of, and advice on, NDA submission and CTD
- Support with clinical compliance inspection of documents and GCP
- Support with PMDA communication (response to questions) after NDA submission
- Assistance for revision of CTD for the Drug Committee
- Review report and CTD masking support
- Advisory on clinical development strategy for product life cycle management
