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Regulatory Affairs Blog Posts

November 18, 2020 Regulatory Affairs

A Roadmap to Authorization: Using Science to Prepare a MAA

It is critical to understand the key procedural milestones involved in the…

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November 11, 2020 Regulatory Affairs

Meet the Expert: Matthew Weinberg

Get to know Matthew Weinberg! In our latest colleague spotlight, he is…

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November 11, 2020 Regulatory Affairs

Scientific Data Works: Using Science to Navigate the Global Regulatory...

Regardless of geographical location, one constant that remains across all regulatory agencies…

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November 3, 2020 Regulatory Affairs

Why Drug Approvals Are Never Slam Dunks

In the world of the FDA, sure things don’t exist. But, our…

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October 26, 2020 Regulatory Affairs

Filing Using Registry-Based Studies? EMA Issues Draft Guidance

Recruiting clinical studies in a niche disease area can be challenging, but…

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October 20, 2020 Regulatory Affairs

How to Present Scientific Data That Generates Regulatory Approvals

The best path to regulatory success for your drug's development is to…

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October 7, 2020 Regulatory Affairs

The Key to Understanding Pricing and Reimbursement in the Nordics

Choosing the right Pricing and Reimbursement strategy, and doing so early in…

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October 6, 2020 Regulatory Affairs

10 Things You Need to Know about FDA’s Final Rule...

If you’re interested in importing an approved product to the United States…

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