Drug and Medical Device Regulatory Strategy and Medical Writing
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Umen & Co. offers a full range of strategic regulatory consulting and medical writing services. Our core strength lies in combining these two capabilities to create documents that are objective, persuasive, and supportive of labeling.


Drug Development Strategy

CTD and eCTD Preparation

IND, NDA, BLA, MAA Preparation and Strategy

FDA Meeting Coordination and Information Package Preparation

Advisory Committee Presentations
Advisory Committee Training

Rx to OTC Switches

Regulatory White Papers


Integrated Summaries
(e.g., ISE, ISS, Clin Pharm, etc.)

CTD Clinical Overview (2.5)

CTD Clinical Summaries
(2.7.1, 2.7.2, 2.7.3, 2.7.4)

Study Reports


Investigator's Brochures

Document Templates

Umen & Co.  The Leader in NDA Preparation Since 1981