"We engage Paracelsus at Aires (and did so at our previous company, Palkion) and have been very pleased with Dr. Furman’s knowledge, expertise, advice, timeliness, and work ethic..."
Aires Pharmaceuticals
Hiroko Masamune, PhD

Regulatory Affairs and Communication


  • Regulatory consulting and advising (US and ex-US)
  • Communication liaison between global Health Authorities (e.g., U.S. FDA, Health Canada, EMEA) and Sponsor
  • Pre-IND/IND/NDA (FDA PDUFA) meeting support
    • Meeting preparation (e.g., meeting requests, briefing documents, rehearsals)
    • Attendance with Sponsor at formal meetings
  • Evaluation of need for (and value of) FDA pre-IND consultation
  • Preparation for and Sponsor representation at FDA Advisory Committee meetings
  • Gap analysis/needs Assessment
  • Determination of preparedness