Dr. Xiaoxia Li
Dr. Xiaoxia Li

From Concept to Market: The Strategic Journey from IND to NDA

By Dr. Xiaoxia Li

The Investigational New Drug (IND) application and the New Drug Application (NDA) stages are critical milestones in drug development, but they are different applications. Developers and sponsors must understand which application requires which data and when. Here we highlight strategies, hurdles and data required for successful drug development from IND to NDA.

Continue reading

Nick Recht
Nick Recht

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht

Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.

Continue reading

Philip Remedios 2023
Philip Remedios 2023

Navigating the New Normal: Achieving R&D Success in Hybrid Work Environments

By Philip Remedios, Renée Bailey

Implementing a hybrid work environment with R&D teams yields significant benefits but also presents challenges. In this article, we explore how to achieve successful R&D programs within the context of hybrid environments and share key strategies and best practices to effectively navigate the challenges, including the safeguarding of sensitive information and data.

Continue reading