Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Over the last couple of months, I’ve written a series of blog […]
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In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]
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