Regulatory Support

Accelera has the experience and expertise to provide regulatory support services required throughout the drug development process:
  • Investigational New Drug (IND) preparation
  • Investigator Brochure (IB) preparation
  • Investigational Medicinal Product Dossier (IMPD) preparation
  • Common Technical Document (CTD) preparation
  • Review of Sponsor-prepared documents
  • Due diligence, gap analysis
  • Safety Assessments/Expert Reports
  • Orphan Drug Application
  • Calculation of the Permitted Daily Exposure and preparation of the “PDE determination strategy” document.