Regulatory

  • Regulatory Strategy and Planning

    • Support defining regulatory strategy for US and OUS approval

    • Support defining regulatory requirements for clinical trials based on GCP, ISO regulations

    • Develop quality processes and reports to regulatory authorities

  • Regulatory Submissions

    • Develop of submission table of contents, contents for IDE, PMA, 510k and HDE submissions

    • Develop pre-IDE presentations and PMA-panel presentations

    • Communicate with FDA during the IDE, PMA, 510k and HDE submissions and Health Canada applications including responses to deficiency letters

    • Communicate with Notified Body for CE Marking and Health Canada

  • Medical Writing

    • Study annual progress reports to regulatory authorities

    • Clinical study reports to regulatory authorities

    • Literature review for regulatory agencies submissions

    • Develop training materials and promotional materials for clinical trials and post-approval studies and post-market registries

    • Develop investigator meetings, abstracts, manuscript and poster presentations

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