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Services

MedExpert Consulting, Inc. provides a wide range of strategic, executive-level consulting services, along with technical, drug development expertise for small molecule pharmaceuticals, large molecule biologics, cancer vaccines, and cell-based therapeutics ranging from discovery-stage preclinical programs through NDA filing.  
  • Executive level (CMO, CSO, VP) management
  • Fundraising from public and private sources
  • Successful positioning and execution of strategic business transactions, including partnering or M&A 
  • Due diligence of licensing, acquisition, and investment opportunities
  • Comprehensive drug development of preclinical and clinical therapeutic programs
    • Target product profile and comprehensive clinical strategy planning
    • IND planning and preparation
    • Clinical trial design, protocol preparation, execution, and critical data analysis
      • Phase 1 first-in-human (FIH) single ascending dose, multiple ascending dose, and clinical pharmacology studies
      • Phase 2a proof-of-concept PK / PD studies
      • Pivotal Phase 2 / 3 studies
    • Engagement with regulatory authorities in the U.S. Europe, and other geographic regions
    • Biomarker development and integration into clinical trials
    • Establishment and management of Advisory Boards