ACT Oncology staff has significant experience with all stages of drug development, from pre-IND meetings and IND submissions to end-of-phase 2 meetings, pre-NDA/MAA meetings and NDA/MAA submissions. We can support strategic discussions leading to IND development and project management the entire submission process.
- Assistance with pre-IND Meetings
- IND Compilation and Submission
- IND Maintenance
- IND Amendments
ACT Oncology’s NDA submission experience includes substantial eCTD formatted submissions. We can assist in strategy, implementation and project management for the development and submission of electronic marketing applications.
- Assist with pre-NDA/MAA Meetings
- NDA/MAA gap assessment
- NDA/MAA Development Strategy
- Project Manage the cross functional compilation of NDA/MAA
- Manage submission vendors
- Risk Mitigation Strategies related to NDA/MAA submission consistency and quality control