Get Started


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 written documents, oral communication, and face-to-face meetings.

Our regulatory strategy services include:

  • Regulatory due diligence
  • Critical review and gap analysis of submissions
  • 505(b)(2) strategies
  • FDA correspondence interpretation and regulatory guidance
  • FDA meeting and teleconference participation
  • Regulatory meeting coaching and preparation
  • Expedited regulatory pathways
  • Strategic product placement
  • Complete response to Clinical Hold
  • Integrated Development Plans
  • OTC monograph deviations