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Dedicated for Approval®

Aleon stands ready to support you no matter where you are in your journey. Whether you are in early-stage development, preparing your first IND, conducting ongoing clinical trials, or are planning for your NDA/BLA, our team will work closely with you to achieve the success you need to push your program forward.

Click on a circle to learn more about how Aleon can help with each agency

Early Development Consultation

Craft your strategy and approach your development plan with full confidence.

  • Early-stage Consultation and Guidance
  • Feasibility Assessment for Orphan Drug Designations
  • CMC Program Design and Evaluation
  • Nonclinical Program Design and Evaluation

Strategy Development

From nonclinical plans to engaging with global regulatory agencies, Aleon can help you develop a streamlined approach.

  • Global Regulatory and Clinical Development Strategy
  • Health Authority Consultation
  • Rare Disease Treatment Development
  • Expedited Development Pathways

Regulatory Affairs

Aleon has supported many sponsor companies from initial formal meetings, IND activation for their novel products, to NDA/BLA approval.

Aleon’s team has extensive experience with global health authorities. We can help you establish and implement a successful global strategy from start to finish as you develop your pipeline.

Clinical Development

Ensure strong clinical trials and pave the way for your program’s success.

  • Clinical Protocol Development and Optimization
  • Clinical Development Strategy and Planning
  • Clinical Trial Feasibility and Site Selection
  • Patient Enrollment Strategy and Planning
  • CRO Identification and Selection
  • CRO and Clinical Study Management
  • GCP Compliance and Quality Assurance
  • Clinical Study Report Preparation and Review


Ensure you are in compliance with relevant requirements for your program.

  • Safety Reports
  • Risk Management Plan (RMP)
  • DSUR Preparation and Submission
  • PSUR Preparation and Submission

Quality and Compliance

Prepare for audits and maintain compliance with governing bodies throughout your development process.

  • Risk Assessments
  • Regulatory Inspections and Audits Preparation
  • Best Practices in cGMP, GLP, and GCP

Aleon Pharma International

Headquarters: Parsippany, NJ, USA

China Office: Suzhou, China

Copyright 2024 - Aleon Pharma International, Inc.