FDA CDER - Umen & Co. Drug and Medical Device Regulatory Strategy and Medical Writing
ICH - Umen & Co.
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"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.

opportunities may
involve complementing teams with
experienced regulatory consultants..."*



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their respective owners


*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.

*Drug DocUmentation System:
U.S. Patent Nos. 5734883, 5963967, 6205455, US6505218, 6854086

Umen & Co.  The Leader in NDA Preparation Since 1981