Increasing Product Success

Increase your product's chance of expedited approval and greater patient access with global program development guidance from seasoned experts specialized in regulatory intelligence, policy and strategy.

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