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