I edit all regulatory documents from the Common Technical Document submitted to the FDA, including study protocols, clinical study reports, investigator’s brochures, Investigational New Drug applications, and New Drug applications. I am knowledgeable of FDA regulatory guidelines, such as ICH E3, and E6, Good Clinical Practices. I have done coursework at the University of California San Diego that reviewed all stages of clinical trials, the drug development process, and FDA regulations. I understand the utmost importance of documenting the efficacy and safety of a given drug. I provide meticulous and rigorous editorial scrutiny of all documents aiming for accuracy and compliance with FDA regulatory guidelines. Please contact me to discuss your editing needs.