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.

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