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Regulatory Affairs

Food and Drug Administration (FDA) Services

Aleon will support you in achieving every regulatory milestone throughout your journey. We have successfully completed:




Formal FDA meetings & teleconferences


Expedited Programs & ODDs



Formal Meetings with FDA

  • INTERACT Meetings
  • Pre-IND Meetings
  • End-of-Phase I Meetings
  • End-of-Phase II Meetings
  • Biosimilar Initial Advisory (BIA) Meetings
  • Biological Product Development (BPD) Meetings
  • Q-Submissions
  • Pre-NDA/BLA Meetings
  • Other Type A/B/C Meetings

INDs and NDAs/BLAs

  • IND Preparation
  • NDA/BLA Preparation
  • Gap Analysis for CMC, Nonclinical, and Clinical Data
  • SEND Dataset Review and Validation
  • IND/NDA/BLA Annual Reports and Amendments

ODDs and Expedited Programs

  • Orphan Drug Designations (ODD)
  • Rare Pediatric Disease Designations (RPDD)
  • Fast Track Designations (FTD)
  • Breakthrough Therapy Designations (BTD)
  • Regenerative Medicine Advanced Therapy Designations (RMAT)
  • Priority Review Designations
  • Accelerated Approval

Regulatory and Medical Writing

  • Investigator's Brochure (IB)
  • Initial Pediatric Study Plan (iPSP)
  • Study Reports
  • DSURs

eCTD Publishing and Submission

  • Meeting Requests and Meeting Packages
  • INDs/NDAs/BLAs
  • Safety Reports
  • Protocol Amendments
  • Information Amendments
  • DSURs
FDA development process diagram