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"I've asked
 Umen & Co.
to help me with every submission I've
ever been
responsible for
since 1985.

They have an extraordinary
track record in this business."

 

Michael M. Kitt, M.D.

Senior Vice President, Development

Theravance Inc.

 

 

 

 




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Simply put, we are the experts when it comes to integrating the strategy and the content in a drug application!

Good Medical Writing Requires a Solid Regulatory Strategy

Our clients repeatedly request our assistance because they know that despite the abundance of regulatory consultants, CROs, and medical writers, no others are able to blend strategic regulatory consulting and medical writing like Umen & Co.

Umen & Co. Strives for Excellence

Executives understand the importance of creating a drug application that is strategically sound, internally consistent, timely, and well-written, as the NDA/BLA is the only form of a drug that most regulators will ever see. Ultimately, decision makers choose Umen & Co., because they know we treat each application as an example of their company's finest work.

Team Dynamics Play a Critical Role

Our listening skills and sensitivity to all types of issues and personalities enable us to seamlessly integrate with our client's team. We tailor our approach to the project needs and the team's task maturity. For inexperienced teams, we provide guidance, leadership, focus, and implementation. Being sensitive to more experienced teams, we support the team leadership by offering strategic input for critical issues.

There is No Substitute for Experience

We have a breadth of knowledge that goes beyond an understanding of the individual technical regulations and guidances. Our experiences across therapeutic areas and reviewing divisions of FDA enable us to understand the issues and bring insights with considerable depth to bear on the project.

There is More to Preparing an NDA/BLA Than "Publishing"

Our clients know that preparing a regulatory submission requires more than just cobbling together various documents. An effective application must incorporate the following attributes:

    

A fully supported PI

    

Sound clinical and regulatory strategy that will maximize the probability of first-cycle approval
     Consistent and cohesive messages at all levels of the submission (overviews, summaries, study reports, protocols, etc.) and across disciplines (quality, safety, efficacy)
     A master table of contents that is not only compliant with the regulations and guidances, but also consistently reflected in the tabular listing of studies, the ISE, the ISS, and the various Module 2 summaries

Umen & Co.  The Leader in NDA Preparation Since 1981