Regulatory writing

ICH eCTD submissions (IND, NDA)

Mod 2:

Nonclinical Overview

Clinical Overview

Clinical Summary

Mod 5:

Clinical Study Report (CSR)

Integrated Summary of Efficacy (ISE)

Integrated Summary of Safety (ISS)

Annual Reports (IND, NDA, IDE)

IND

Investigator’s Brochure (IB)

Orphan Drug Designation

AMCP Dossiers
Journal Research Articles
Journal Reviews
Medical Education Reviews
Posters / Slides for Presentation
Editing