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Kathy joined Umen & Co. in 1990 after previously working at Hershey Medical Center and Johnson & Johnson. Kathy has focused primarily on tackling strategic issues and providing medical writing services related to the preparation of investigator brochures, various FDA Meeting documents, clinical study reports, integrated summaries of efficacy and safety, CTD clinical summaries (eg, 2.7.3 and 2.7.4) and CTD clinical overviews (ie, 2.5).  She is very well versed in the technological aspects of drug applications including eCTD, CDISC, SPL and PIM. In addition, she is a co-inventor of the Drug DocUmentation SystemTM and various other drug document production systems.*

Kathy holds a Bachelor of Science degree in biology Summa Cum Laude from Clarion State University.

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

Umen & Co.  The Leader in NDA Preparation Since 1981