As President of EG Consulting, Inc., Dr. Elizabeth Gordon provides strategic, regulatory, and technical advice and full project and document management support to the pharmaceutical, biologics and biotechnology industry in all areas of product development from discovery through post-marketing. EG Consulting, located in San Diego, California, provides expert strategic and regulatory advice on issues related to expedited drug development programs, interactions with the FDA, and regulatory procedures and policies.
Dr. Gordon acts as a liaison with FDA on behalf of client pharmaceutical and biotechnology companies. Technical areas of expertise include: preparation and/or evaluation of pre-clinical and clinical data; chemistry, manufacturing, and controls information; and pharmacology and toxicology data submitted to the FDA to support the safe and effective use of drug and biological products specified by Investigational New Drug (IND), Biologics License Application (BLA), and New Drug Application (NDA) requirements. She is responsible for the preparation of all regulatory submissions to FDA including briefing packages to support communications and meetings with the regulatory authority, IND, BLA, and NDA submissions , applications in the traditional (FDA Form 1571) and Common Technical Document (CTD) format and the transition to this submission format, amendments, supplements, and advisory committee briefing packages. She also provides expert medical writing services including clinical protocols, clinical study reports and other scientific reports.
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