I edit all regulatory documents from the Common Technical Document (CTD) submitted to the FDA’s Center for Drug Evaluation and Research (CDER), including the study protocol, clinical study report (CSR), investigator’s brochure (IB), Investigational New Drug Application (IND), New Drug Application (NDA) Biologics License Application (BLA), and Periodic Benefit-Risk Evaluation Report (PBRER). I am knowledgeable of regulatory guidelines, such as ICH E3 and E6 on good clinical practices.

 

I have done coursework at the University of California San Diego reviewing all stages of clinical trials, the drug development process, and FDA regulations. I am a member of RAPS, Regulatory Affairs Professional Society, and I understand the utmost importance of Good Documentation Practices (GDPs) documenting the efficacy and safety of a given drug, biologic, or medical device. I provide meticulous and rigorous editorial scrutiny of all documents aiming for accuracy and compliance with FDA regulatory guidelines. I can provide QC editing and annotation of documents submitted to the FDA. Please contact me to discuss your editing needs.