Precision for Medicine Acquires ACT Oncology         

IND/NDA Submission Consulting

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

We're changing our name and website to reflect our exciting new capabilities since joining Precision for Medicine. Please visit us at precisionforoncology.com to see how we’re delivering the next generation of CRO services for oncology innovators.