Quality System and Regulatory Documentation

    We offer a variety of specialized documentation
    services, from the preparation and submission of FDA
    market clearance documentation (Pre-Market Approval
    (PMA) and Substantial Equivalence (510(k)
    submissions) to procedure and policy documentation.  

    Our specialty is working with small manufacturers to
    ensure that process and policy documentation is
    complete, effective, and compliant with all internal and
    external requirements.

    Contact us for more information.  We'll be glad to
    discuss any upcoming projects you may have.  

  • FDA submissions
  • FDA foreign manufacturer representation
  • Policy and procedure writing
  • Training
  • Other regulatory services
Innovative Synergies International
Regulatory Documentation:
Powerful, Positive,
Creative and
Synergistic Solutions
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