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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:
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A fully supported PI |
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Sound clinical and
regulatory strategy that will maximize the
probability of first-cycle approval |
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Consistent and
cohesive messages at all levels of the submission
(overviews, summaries, study reports, protocols,
etc.) and across disciplines (quality, safety,
efficacy) |
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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 |
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