Blog | Veristat Insightful Perspectives

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


Veristat has experience in preparing more than 120 marketing applications.  Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:

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

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

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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