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