Your Guide Through the Global Regulatory Maze

Synchrogenix's global regulatory strategy consulting team is comprised of seasoned experts specialized in regulatory intelligence, policy and strategy who provide customized global program development and guidance. 

Global Regulatory Strategy Consulting Services

  • U.S. Agent for global life sciences companies
  • Gap analysis of development programs, global dossiers and regulatory agency correspondence to increase probability of success for approval and patient access
  • Agency engagement preparation, communications and leadership
  • Labeling consultation, preparation and negotiations with regulatory agencies
  • Proactive stakeholder consultation to achieve alignment
  • Consideration of expedited regulatory pathways
  • Due diligence assessments for in-licensing and partnering, including proposals to increase value proposition
  • Global submission preparation and leadership focused on incorporation of regional regulatory requirements