Regulatory Services for Drug Development Programs in the United States

  • Pre-IND meeting preparation, communication with US-FDA, EMA (end-to end)
  • Develop regulatory strategy
  • Investigational New Drug (IND) preparation, submission (CBER, CDER)
  • eCTD submission to regulatory agencies
  • Type A, B, C, EOP1, EOP2, pre-NDA meetings preparation and communication
  • Preparation and submission for Orphan Drug Designation (ODD), Priority Review
  • Voucher (PRV), Qualified Infectious Diseases Product (QIDP) designation
  • Special protocol Assessments (SPA)