Summit Drug Development Services
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Services Overview
Drug development services offered by Summit include:
Strategic Planning
:
CMC
Preclinical
Clinical
Regulatory
Chemistry, Manufacturing and Controls (CMC)
cGMP Auditing and Training
CMO Outsourcing
Preclinical Studies
Vendor Selection
Study Designs Management and Monitoring
Study Report Writing
Clinical Trial Design and Analysis
:
Protocol Design
Clinical Development Plans
Protocol and Clinical Study Report Writing
Regulatory Submissions and FDA Liaison
:
Target Product Profiles
Pre-IND and IND
Appendix M
CTD/NDA/BLA
IND Annual Reports
Project Management
Copyright © 2007 Summit Drug Development Services, LLC
Updated:7/19/07