Our Work

With innovation, integrity, and continuous improvement as our anchors, we help clients achieve something remarkable - bringing life-saving drugs and treatments into the world that truly make a difference.

Aleon has authored several position papers to share our expertise and demonstrate the value we can bring to your project.

Regulatory Insights: Assessment Aid: Why Should You Participate in this Voluntary FDA Oncology Center of Excellence Program?
Summary
Check out Aleon’s Regulatory Insights article titled Assessment Aid: Why Should You Participate in this Voluntary FDA Oncology Center of Excellence Program? where our team outlines the purpose of the Assessment Aid, why you should participate, how to get started on preparing the Assessment Aid, and how Aleon can support you with Assessment Aid preparation.
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FDA Pre-IND Meeting: A Critical Step for Your Program
Summary
Check out Aleon’s position paper: FDA Pre-IND Meeting: A Critical Step for Your Program () where our team outlines when a pre-IND meeting is critical, how your program might benefit from having a pre-IND meeting, the overall timeline leading up to a pre-IND meeting, and how Aleon can help to prepare your team for a successful pre-IND meeting with the FDA.
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Regulatory Insights: FDA Accelerated Approval Strategy for Oncology Drug Development
Summary
In this article, you will learn: (1) Current FDA considerations pertaining to accelerated approval, (2) FDA expectations and recent accelerated approvals, and (3) Confirmatory trials following accelerated approval.
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Regulatory Insights: Considerations in Seeking US FDA Oncology NDA/BLA Approval with Predominantly Asian Clinical Data
Summary
In this position paper, you will learn (1). US FDA regulations and FDA/ICH guidance on the utilization of foreign clinical data (2). Recent FDA NDA/BLA approvals predominantly dependent on Asian clinical data (3). Key insights into FDA policies to effectively leverage Asian clinical study results
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Please check back for new position papers authored by Aleon.

Aleon Pharma International

Headquarters: Parsippany, NJ, USA

China Office: Suzhou, China