Quality Assurance Oversight


Experienced in Quality Assurance Management of Third Party Contractors

including Manufacturing and Packaging.  We will insure that your Clinical Trial

Materials or Marketed Product are compliant with Applicable Regulations.


  • FDA U.S. Agent Representative 
  • Contract Functional Group/Department Head Manager
  • Quality Agreement Preparation and Negotiation
  • Manufacturing Batch Record Pre-Approval, Review, and Disposition
  • Packaging Batch Record Pre-Approval, Review, and Disposition
  • Contract Quality Assurance Project Management