Aleon Pharma
International
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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.
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.
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.
- Regulatory Due Diligence
- Risk Assessments
- Regulatory Inspections and Audits Preparation
- Best Practices in cGMP, GLP, and GCP