Raymond C. Lamy, MS

President - US FDA Regulatory Expert

Arciel, LLC

Ray established ARCIEL, LLC, of California, in 2008 after several years of industry experience at pharmaceutical, biotech and international consulting companies. He brings 35+ years of pharmaceutical industry experience to best support sponsor drug development and regulatory submissions by providing high level expert consulting in US regulatory operations. This includes regulatory submissions life-cycle management, FDA interactions (including liaison with FDA on behalf of sponsors), regulation / guidance interpretation, and strategic planning.

Michelle Currie

Medical Writer

M. Currie Consulting

Michelle is a regulatory medical writer with more than 25 years of clinical research experience. She has been a major contributor to multiple successful initial Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs). She has authored clinical study protocols and clinical study reports (CSRs) for all phases of clinical development. Michelle also has authored summary sections of regulatory licensing applications for pharmaceutical, biotechnology, and device products, in a wide spectrum of therapeutic areas.