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