I have experience in authoring documents for inclusion in the following regulatory submissions:
  • NDA and sNDA
  • BLA
  • pre-IND and IND
  • Clinical Pharmacology Expert Reports
  • Briefing Packages for
I have regularly responded to regulatory questions on marketed products resulting from PSUR and EU Licence Renewal submissions.

I have prepared and delivered presentations for the following regulatory authorities:
  • FDA
  • CHMP
  • Health Canada
  • MHLW
  • SFDA
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FRY Medical Communications Ltd, Medical Writing, Presentations & Publications, Clinical Development Strategy