November 28, 2016

Regulatory Services

regulatoryThe story of your technology requires the regulatory submissions that unlock the door to key markets. Telos Partners understands the complexities of regulatory pathways and creates submissions that are clear, on point, and on time. Whether seeking novel indications or surrounding your technology with multiple product claims, our expertise will help you win in a competitive landscape.

  • Selection and writing of regulatory submissions, including 510(k), PMA, IDE and dossiers for international markets
  • Comprehensive literature reviews, clinical evaluation reports, and meta-analyses
  • Strategic planning and execution of new indications
  • Confident, proactive interaction with FDA, notified bodies and other worldwide regulatory authorities
  • Thorough 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