IND/NDA Consultation
Dt&CRO and Radyus Research provide support for international expansion in the fields of IND and NDA through GLP-certified tests and strategic analysis.
Consultation plans
Three plans, built stage by stage
| Plan | Stage 1 | Stage 2 | Stage 3 |
|---|---|---|---|
| Early Development Plan | Included | — | — |
| Pre-IND Plan | Included | Included | — |
| IND Approval Plan | Included | Included | Included |
- 01
Review IND, NDA approval process and requirements · Consult non-clinical trial design
- Prepare project introduction meeting
- Identify category / track designation
- Consult efficacy study design
- Develop non-clinical study strategy (administration route, indication, etc.)
- 02
Prepare pre-IND meeting · Develop pre-IND meeting strategy
- Determine non-clinical trial item(s)
- Confirm strategy for IND approval
- Confirm non-clinical study design from pre-IND meeting
- Write protocol synopsis
- 03
Confirm IND strategy · Consult submission documents
- Review and consult essential documents for IND submission (CMC / GMP / non-clinical study)
- Represent sponsor in RA for IND submission
- Write IB and protocol development
About our partner
Radyus Research
Radyus Research offers strategic analysis and consulting services for INDs and new drug approvals from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) through its personnel, whose expertise and networks encompass pharmaceutical companies and academia.