“In 2007, Kalypsys took a chance by signing on as Dr. Grace Furman's first client as an independent consultant. Her work on that project immediately justified the risk taken..."
Kalypsys
John Fikes, 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