Regulatory Strategy

Our consultants are experts in Food and Drug Administration (FDA) and European Union regulations and guidelines and provide insight into current regulatory interpretation. We support clients in their regulatory interactions through oral communication, written documents, and face-to-face meetings.

Our regulatory strategy services include:

  • Strategic Regulatory development plans
  • Regulatory due diligence
  • Critical review and gap analysis of submissions
  • 505(b)(2) strategies
  • FDA correspondence interpretation and regulatory guidance
  • Integrated Development Plans
  • FDA meeting participation
  • Regulatory meeting coaching and preparation
  • Expedited regulatory pathway strategy
  • Strategic Product Placement
  • Complete response to clinical holds
  • OTC monograph deviations
  • Development of key messages for marketing applications