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Having contributed
to approximately
15-20%
of the drugs
approved in the
past three decades

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Drug and Medical Device Regulatory Strategy and Medical WritingUmen & Co. provides strategic regulatory consulting and medical writing services to the pharmaceutical and biotech industries. Our core strength lies in combining these two capabilities to create documents that are objective, persuasive, and supportive of labeling. We assist clients in preparing various NDA/BLA documents and in projects ranging from pre-IND information packages to post-approval supplements.

 

Understanding the Differences and Effectively Transitioning Between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS)
by David N. Schwartz, BS
Michael J. Umen, PhD
Kathy Nomides
Mary Vanderhoof, MS

As printed in Drug Information Journal, Vol. 44, pp. 641-648, 2010.
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Umen & Co.  The Leader in NDA Preparation Since 1981