How to Prepare for Pre-Approval Inspection (PAI): An Expert Guide
Learn how to master the FDA pre-approval inspection process with our guide including strategies for success and insights into Xybion SEND Intelligence Services.
NDA Submission: A Key Milestone in the Drug Development Journey
Explore the significance of NDA submissions as a pivotal milestone in the drug development journey, unraveling critical insights and considerations. Read blog.
SEND Datasets FDA: Enhancing Compliance and Quality in Drug Development
The introduction of the Standard for Exchange of Nonclinical Data (SEND) by the FDA marks a transformative step in drug development. This standardization is designed to streamline the process to collect and present study data submission, ensuring a high level of compliance and quality.
Mastering CDISC SEND Standards: A Guide to Ensuring Compliance
Mastering CDISC SEND standards doesn’t have to be complicated. By reading this guide, learn how to improve CDISC SEND standards and ensure compliance.
Top Strategies for Ensuring the Success of Your New Drug Application (NDA)
Developing a successful new drug application (NDA) requires careful planning and execution. Learn more on how to increase your chances of success.