"According to FDA reviewers,
unfamiliarity with FDA regulations and the drug
application process
is a key problem for inexperienced sponsors and
results
in poor quality submissions.
Sponsor-side
improvement
opportunities may
involve complementing teams with
experienced regulatory consultants..."*
*Source: Independent
Evaluation of FDA's First Cycle Review Performance
- Retrospective Analysis Final Report - January 2006
Now
in its third decade, Umen & Co. is a boutique consulting
firm continuing to provide
strategic regulatory consulting and medical writing
services to clients across the pharmaceutical and
biotech industries. From early development to post-approval,
we work side-by-side with our clients, guiding them
throughout the drug development process and preparing key
documents for submission to FDA and its counterparts
worldwide.
What Makes Umen & Co. Unique?
Our Experience
We have many years of
combined experience - with a team that has worked
together for over 15 years
We have contributed to
approximately 15-20% of the drugs approved in the
past three decades across a wide range of
therapeutic areas
Our vast
project experience ranges from first in class
products, to new indications, to lifecyle extensions
including new dosage forms, and Rx to OTC switches
We are electronic
submission savvy, having participated in some of the
earliest e-submission pilots and numerous subsequent
eCTDs
Our Approach
We combine strategic
regulatory affairs expertise and superior medical
writing to produce documents that are objective,
persuasive, and supportive of labeling
We remain focused on
our clients by taking on only a limited number of
projects and generally working on just one major
submission at a time
We meet
project deadlines without sacrificing quality
Our Ingenuity
We stay on
the cutting edge in the industry by constantly
fine-tuning our processes
Many of
the approaches we have developed for streamlining
submissions have gained widespread industry use:
The document prototypes that we developed pre-ICH
became the predecessors to the CTD document
templates used today by many of the world's leading
pharmaceutical companies
We pioneered
structured authoring in the industry and patented*
the first drug document production system
From the early 1980's
to the present, the take-home message from our NDA
preparation tutorials has been "An NDA is a document
to support a package insert." This concept is now
embraced by FDA as evidenced by the Agency's Target
Product Profile initiative.
Now
in its third decade, Umen & Co. is a boutique consulting
firm continuing to provide
strategic regulatory consulting and medical writing
services to clients across the pharmaceutical and
biotech industries. From early development to post-approval,
we work side-by-side with our clients, guiding them
throughout the drug development process and preparing key
documents for submission to FDA and its counterparts
worldwide.
