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Professional Toxicology Services
"It has been a pleasure to work with the experienced drug development team at Paracelsus, Inc. who have..."
Selexagen Therapeutics, Inc.
Patrick M. O'Connor, Ph.D., CSO
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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