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Plenary Session Presentation: Putting Science First in Rare Disease Studies
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
Successfully transitioning from academic or bench-top production to manufacture clinical-grade material is not an easy feat. There are many factors new sponsors must consider when determining readiness to file an Investigational New Drug (IND) from a manufacturing perspective. FDA guidance for INDs for Phase 1 points out that ‘insufficient data to make an evaluation of safety is the only basis of a clinical hold based on the CMC section.’
Listen to the full episode on Veristat’s Advancing Revolutionary Therapies (ART) Podcast to learn more about the key CMC fundamentals and pitfalls of preparing for an IND.
Meet Veristat. Learn More: Regulatory Affairs, Operations and Consulting
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Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...
1 min read
Mar 19, 2024 Veristat Events
Meet Veristat in Basel at the Swiss Biotech Day, 22-23 April 2024
With nearly 30 years of experience in clinical trial...