Useful links:






    FDA Guidances

    EMA Guidances

Mitchell Pharmaceutical Consulting, LLC
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Mitchell Pharmaceutical Consulting provides a full complement of services.  We will work with you one on one, as part of a project team, or across your entire organization.  These services include:

    Clinical Pharmacology

    • Phase 1-4 protocol design and development
    • Pharmacokinetic / toxicokinetic data analysis and interpretation
    • Clinical study report writing 
    • Clinical pharmacology sections of investigator brochures and other regulatory documents, including:
      • Periodic Safety Update Report (PSUR)  
      • End of Phase 2 and pre-NDA meeting request and briefing package
      • MPA scientific advice briefing packages
      • Label updates / revisions
      • EU renewal for marketed product 
      • Clinical Pharmacology sections of CTD 
    • Writing of abstracts, posters and manuscripts

    Project Management

    • Generation of development and risk management plans
    • Development of target product profile (TPP)
    • Development of:
      • Product review process
      • Team and governance structure handbook
      • Clinical study best practices
    • Generation of product communication plan, or annual corporate communication calendar


Please contact Mitchell Pharmaceutical Consulting for help with any services not listed above.  Dr. Mitchell has a network of consultants that can assist you with areas outside his area of expertise.
Contact us at, or 303-921-3704 
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