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Regulatory Submissions (9)

2 min read

Streamline the Medical Writing Process for Simultaneous Submissions

August 6, 2018

When a team faces multiple submissions in a short timeframe or even simultaneous submissions, uncertainty over timeline organization and the best way to utilize medical writers can be paralyzing.

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2 min read

Top 10 Operational Tips for Navigating Complex NDA/MAA Submissions

July 27, 2018

No two New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs) are the same. However, they all have common aspects that create the opportunity for streamlined operational tips. 

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