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 and Medical Writing
- Chemistry, Manufacturing and Controls (CMC)
- Nonclinical 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.
Aleon's Services
Regulatory & Medical Writing
Aleon’s regulatory and medical writing team is staffed with former FDA reviewers and industry experts. In addition to drafting documents for INDs/NDAs/BLAs, the writing team has successfully completed more than 30 special applications and received 20+ Orphan Drug Designations.
- Document Preparation for INDs, NDAs, and BLAs
- Document Preparation for formal meetings with health authorities
- Orphan Drug Designation (ODD) Application Preparation
- Fast Track Designation (FTD) Application Preparation
- Breakthrough Therapy (BTD) Application Preparation
- Accelerated Approval
- Regenerative Medicine Advanced Therapy Designation (RMAT)
- Priority Review Designation
- iPSP Preparation
- Annual Reports / IND Amendments
- DSURs
Get in Touch
Chemistry, Manufacturing and Controls (CMC)
Nonclinical
Clinical
eCTD Publishing and Submission
Regulatory Milestones
Aleon provides end-to-end IND and NDA/BLA services, from strategy/planning, to writing/review, and eCTD submission. With more than 100 INDs and 10 NDA/BLAs successfully submitted, the Aleon team is ready to help with the major submissions listed below and more:
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
Ensure you get the most valuable feedback possible during your formal meetings with health authorities by consulting with our seasoned team, including former FDA senior reviewers and industry experts. Aleon provides full meeting preparation (writing, review) and custom tailored training for your formal meetings, including:
- 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
Strategic Consulting and Special Applications
Whether considering a strategy for your submission or looking to take advantage of special programs to support your drug candidate, Aleon has experts available to recommend next steps for your program as well as draft, submit, and maintain applications on your behalf, including:
- 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
- iPSP Preparation
- Strategy Review & Development
- Expedited Development Timeline
- Gap Analysis
- Due Diligence
