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.

REGULATORY STRATEGY

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
 

MEDICAL WRITING

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

Protocols

Investigator's Brochures

Document Templates

Umen & Co.  The Leader in NDA Preparation Since 1981