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Summit Drug Development Services LLC

15204 Omega Drive, Suite #20
Rockville, MD 20850, USA

Category: Clinical Trials Services (CRO); R&D Services

Used in the following map:

Maryland Biotech Industry Map

Summit Drug Development Services LLC is a drug development services company that offers comprehensive drug development services to the biotechnology and pharmaceutical industry to advance new technologies from discovery to the marketplace. The company was founded in 2004 and is a wholly owned subsidiary of Cornucopia Pharmaceuticals Inc.

Summit's drug development services include: strategic planning; chemistry, manufacturing and controls (CMC); preclinical studies; clinical trial design and analysis, regulatory submissions; and FDA liaison and project management. Its regulatory services include: FDA regulatory submission preparation and review, risk management, product development plans and timelines, electronic submissions in CTD format (eCTD), FDA meeting support & material preparation, Pre-IND/IND, IND maintenance, etc. The company's clinical services include: protocol design and drafting, CRO identification, clinical Study report writing, interpretation of study results.