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Without Umen and Co., preparing an application can involve multiple setbacks.

Umen & Co. gets you from A to B in the straightest line possible.

We begin every project with the end in mind. In other words, we help clients understand what their completed drug application will look like long before the first keyboard stroke. By creating a vision for the final product, we help our clients significantly improve the efficiency of preparing their application by:

    

continuously reinforcing the importance of the PI
     building a logical foundation that will be applied to all aspects of the application from the PI and the overall table of contents to the format and content of every document in the submission
     identifying potential pitfalls and implementing preemptive solutions
     providing recommendations for appropriate staffing throughout the application preparation timeline
     putting into place the necessary infrastructure to meet the needs of the submission
     reducing unnecessary programming
     eliminating the need to backtrack
     using eCTD-compliant document templates (either the client's or our own)
       reducing the number of revision and review cycles

Umen & Co.  The Leader in NDA Preparation Since 1981