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Regulatory Affairs    

  • All aspects of RA department administration and management.
  • All phases of new/upgraded medical device strategy, planning, testing,  review, submission, and support.
  • Experience with direct communication with FDA, including multi-disciplinary face-to-face meetings.
  • Experience with all forms of FDA and ISO audits.

    
Clinical Trials

  • All aspects of testing/trial planning, clinical site selection, implementation, training, monitoring, and reporting.
  • Experience in all phases of new/upgraded protocol and case report form development, review and release from initial strategy to FDA/IRB filing and review.
  • Experience in all levels of new/upgraded protocol release from project administration, data collection to site close-out and reporting.
  • Experience with Radiology Reader studies to support product submissions.
  • Experience with Core Laboratory and ancillary support services selection.


Quality Assurance    

  • All aspects of GCP, cGMP, and QSR
  • Design, implement, and maintain quality systems.
  • Design, develop, and maintain SOPs.


regulatory affairs
RTA Regulatory & Clinical Affairs