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Is Your Complex NDA/MAA Submission Missing One of These Key Elements?

August 21, 2018

By Martha Plaza, MBA; Amanda Truesdale, MA, MBA; and Kimberly Newton, MA. 

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Key Strategies for Overcoming Data Analysis Difficulties During NDA/MAA Submissions

August 14, 2018

By Amanda Truesdale, MA, MBA, VP Biometrics

When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?

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Top 10 Operational Tips for Navigating Complex NDA/MAA Submissions

July 27, 2018

by Martha Plaza, MBA, Project Director, Regulatory Submissions

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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