Drug and Medical Device Regulatory Strategy and Medical Writing
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Michael founded Umen & Co. in 1981, sensing that the pharmaceutical industry needed a reliable consultancy to turn to for strategic regulatory advice and medical writing services. Since then, Michael has contributed to numerous drug and biologic approvals, including over 80 in the U.S. alone. The prototype documents developed by Michael and his co-workers were the predecessors to the regulatory document templates used today by many of the world's leading pharmaceutical companies. He has been working with clients on CTD implementation since the topic was adopted by ICH. As a result of his many accomplishments, Dr. Umen has gained worldwide recognition as a leading regulatory strategist, problem solver, teacher, and writer. He is a co-inventor of the Drug DocUmentation System and various other drug document production systems.*

A member of the Drug Information Association (DIA) since the mid-1970's, Michael has made numerous contributions to the organization and was a recipient of DIA's Outstanding Service Award in 2002. He served on the Editorial Board of the Drug Information Journal from 1991 to 2001, has participated as a tutorial instructor, speaker, session chairperson, and program committee member at DIA meetings and workshops in the United States, Europe, and Japan, and is active in several of DIA's Special Interest Area Committees (SIACs).

Prior to founding Umen & Co., Inc., Michael worked for two Johnson & Johnson companies. He received a Ph.D. in organic chemistry from M.I.T., studied immunology at Harvard Medical School, pharmacology at Philadelphia College of Pharmacy and Science, and business at the Wharton School.

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


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