Services

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.

FDA

EMA

NMPA

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.

FDA

EMA

NMPA

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

Pharmacovigilance

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