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Regulatory Sciences Blog Posts

January 18, 2022 Regulatory Sciences

How a Strong Regulatory Strategy Supports Your Product’s Success

What you should understand about regulatory strategies and why having a good…

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December 21, 2021 Regulatory Sciences

Regulatory Strategy for Clinical Trials in the European Union

From First in Human to Phase III: Starting Your Clinical Trial in…

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December 8, 2021 Regulatory Sciences

Is it Time to Sharpen Your Target Product Profile (TPP)?

Tips from the experts to successfully create this critical tool for drug…

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November 5, 2021 Regulatory Sciences

EMA to Marketing Authorization Holders (MAHs): Submit Type I Variations...

On Friday, October 29, 2021, the EMA published a statement providing marketing…

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November 1, 2021 Regulatory Sciences

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill…

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October 26, 2021 Regulatory Sciences

Understanding Bioequivalence and Product-Specific Guidances

Your guide to understanding product-specific guidances for generic drugs that are bioequivalent…

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October 18, 2021 Regulatory Sciences

Meet the Expert: Daniel Solorio

Our “Meet the Expert” series introduces you to our team of experts…

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October 13, 2021 Regulatory Sciences

European Expedited Regulatory Programs Explained

Do you really know how to accelerate the approval of your innovative…

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