Maximizing the Value of Literature Reviews in Pharma, From Competitive Intelligence to Market Success
In the pharmaceutical industry, systematic literature reviews (SLRs) can be a valuable tool — not just for regulatory submissions, but as a strategic foundation for drug development, clinical trial design, […]
IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to […]
[FREE WEBINAR] It’s All Interconnected: Hidden Traps That Can Derail Your PER: Lessons Learned from the MDR-Compliant CER Writing Experience
Click here to watch the recording of this webinar. With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with […]