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 Umen
& 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.
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Preparing Regulatory Submissions with the
FDA Reviewer in Mind: Use of the Clinical
Review Template
by Mary Vanderhoof, MS
Michael J. Umen, PhD
David N. Schwartz, BS
As printed in Drug Information Journal,
Vol. 42, pp. 349-357, 2008. |
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Read Full Article
(requires Adobe Reader) |
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