Aleon Pharma
International
Services
FDA
NMPA
EMA
Aleon Pharma International, Inc. is a one-stop, full-service global
regulatory affairs consulting firm
When you work with Aleon, we evaluate your program and carefully assemble a dedicated and experienced project team that is tailored to achieve your specific project goals. We have dedicated project teams in both the US and China who are specialized in Regulatory Strategy Development, Regulatory Writing, Chemistry, Manufacturing and Controls (CMC), Preclinical Strategy, Clinical Development, eCTD Publishing, and submissions to the FDA, NMPA, EMA, and other regulatory agencies.
Aleon has worked with many sponsor companies over the years, and our team has developed streamlined processes that enable us to effectively provide high-quality services that help you achieve approval for your innovative drug candidates.
Milestone Submissions
IND Preparation and Submission
- IND Preparation and Submission
- IND Amendment
- Annual Report / DSUR
NDA / BLA Preparation and Submission
- NDA/BLA Preparation and Submission
- NDA/BLA Amendment
- Annual Report
Formal Meetings
with Health Authorities
- Pre-IND Consultation
- Pre-IND Meeting
- End of Phase I Meeting
- End of Phase II Meeting
- Biosimilar Initial Advisory (BIA) and Biological Product Development (BPD) formal meetings
- Q-Submission
- Pre-NDA Meeting
- Pre-BLA Meeting
- Other Type A/B/C Meetings
Expedited Programs and
Special Applications
- Orphan Drug Designation (ODD) Preparation and Submission
- Fast Track Designation (FTD)
- Breakthrough Therapy Designation (BTD)
- Accelerated Approval
- Regenerative Medicine Advanced Therapy Designation (RMAT)
- Priority Review Designation
eCTD Submissions
and More
- In-house eCTD system for all submissions
- Client-specific regulatory affairs support
- Safety reports, DSURs, PSURs
- GLP, GMP, and GCP compliance attendance
