Health Authority Relations

Health Authority RelationsPharmApprove’s approach to regulatory communications honors three core principles.

  • First, the best relationships with regulators are based on candor, transparency and trust.
  • Second, every engagement with regulators is an opportunity to advance your case.
  • Third – and most important — there is no substitute for a sound strategy and clear, compelling messaging as you seek the most direct pathway to approval.

PharmApprove combines a deep understanding of regulators’ behavior, a thorough knowledge of science, and a mastery of communications tools and techniques to prepare our clients for successful interactions with FDA, the EMA and other health authorities worldwide. PharmApprove’s industry-leading team of principals and senior communications strategists can help you address regulatory needs at every stage of development, including:

  • Pre-IND Meetings
  • EOP 2 Meetings
  • Scientific Advice (EMA)
  • Pre-NDA/BLA Meetings
  • NDA/BLA Submissions
  • Challenge Panels
  • Advisory Committee Preparation
  • Oral Explanation (CHMP)
  • Scientific Advisory Group (SAG)
  • Market Access

And, using our proprietary preparation methodologies, our team can address all your communications needs, including:

  • Clinical/Regulatory Plan
  • Regulatory Strategy & Precedent
  • Agency Intelligence
  • Expert Recruitment & Management
  • Challenge Panels
  • Argument Development
  • Background Materials
  • Fast-track/Breakthrough Designation
  • Presentation Development
  • Dossier/Data Review
  • Q&A Preparation
  • Speaker Coaching
  • Negotiation Skills
  • Team Organization
  • Project Management
  • Onsite Facilitation
  • Meeting Logistics

In every aspect of regulatory communications, PharmApprove prepares you to win.