Using Science to Achieve EMA Approval for a First-in-Class Indication
See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic.
You’re developing a drug, biologic, or medical device product. Your end goal is to achieve successful interactions with the regulatory agencies, getting you to the next regulatory milestone. Developing a submission that is rooted in science increases your chances of obtaining regulatory approval for your product.
Learn how our regulatory experts helped one client obtain European Medicines Agency (EMA) approval for a first-in-class oncology indication using science as the driver of success.
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The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
Free Webinar: Effective FDA Engagement
FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...