FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format Blog Post
We explore FDA requirements for providing nonclinical datasets in SEND format, including requirement dates by Study and Submission Types and FDA Center.
FDA’s New ANDA Submissions Guidance: Key Points Blog Post
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, "ANDA Submissions - Content and Format" is intended to assist applicants in preparing complete and fileable abbreviated...
Stay on Track and Get Some Sleep: Marketing Application Best Practices On-Demand Webinar
Without careful execution and the ability to navigate unexpected challenges, marketing application submissions are prone to falling off track and costing valuable time and resources
Simcyp Academic Awards, Grant and Partnership Scheme (GPS) Page
Explore Certara’s Simcyp Academic Awards and Grant Partnership Scheme, supporting innovative research in pharmacokinetics and pharmacodynamics.
Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy Publication
Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in which the characteristics of each patient are considered as opposed to applying a one-size-fits-all alternative. This review provides a brief account of the current knowledge,...
Best Practices for Small to Mid-Size Companies to Advance Drug Discovery Programs On-Demand Webinar
Having the ability to scale with research needs is pivotal to success. Understanding when the time comes to automate processes can be challenging. This webinar will discuss data management practices small to mid-size biotech, and pharmaceutical companies should utilize to...
D360 Platform Partners Page
D360 partners with renowned organizations to provide comprehensive informatics systems for discovery research.
SNDS: Strengths, Limitations and Perspectives for the Largest and Richest Real-World Database in EU On-Demand Webinar
In this webinar, our experts provided an overview of the SNDS and the key working practices to access the database and ongoing SNDS developments, explained the similarities and differences between SNDS and other claims databases, used case studies to illustrate...
