Aleon Pharma
International
Contact Us
Regulatory Affairs
Food and Drug Administration (FDA) Services
Aleon will support you in achieving every regulatory milestone throughout your journey. We have successfully completed:
115+
INDs
130+
Formal FDA meetings & teleconferences
50+
Expedited Programs & ODDs
10+
NDAs / BLAs
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
