November 19, 2016

Scientific, Regulatory and Publication Services

  • Selection and writing of complete regulatory submissions , including 510(k), PMA, IDE and dossiers for international markets
  • Comprehensive literature reviews, Clinical Evaluation Reports, and meta-analyses
  • Data analysis and abstract / manuscript writing that targets your key audiences
  • Budgeting of scientific and regulatory initiatives for meeting investment expectations
  • Pre-clinical and clinical trial design, with clear endpoints to support scientific strategy
    investment decision-making
  • Selection of trial investigators
  • Execution of clinical trial elements, including database management and site
    monitoring, via well-established site relationships
  • Development and negotiation of adaptive and Bayesian scientific approaches with FDA
    in written, teleconference and face-to-face settings
  • Due diligence on IP, stock and/or asset acquisition targets
  • Detailed project plans for your brand strategy, including parallel pathways for
    regulatory, reimbursement and market adoption
  • Detailed presentation development for building investor confidence in your regulatory,
    scientific and market adoption strategies
  • Training and messaging to your sales channels so that your scientific “story” is
    understood and effectively communicated to customers