Registrar Corp Industry Expert

As Manager of the international Drug Team, Melissa Sayers brings extensive knowledge of drug regulatory requirements and electronic submissions across multiple regulatory agencies, including the U.S. FDA, Health Canada, and European-based agencies. She supports companies with Structured Product Labeling (SPL) and eCTD submissions, as well as registration and product reporting requirements for human drugs, outsourcing facilities, third-party logistics providers (3PLs), wholesale distributor (WDD) licensure, and biologics. Melissa also assists companies with understanding and remitting U.S. FDA user fees related to the Generic Drug User Fee Amendments (GDUFA) and the Over-the-Counter Monograph Drug User Fee Program (OMUFA). She has also specialized in radiation-emitting device regulations and report filings with the Center for Devices and Radiological Health.

Background

Melissa has close to 15 years of experience specializing in drug regulatory submissions and compliance requirements. Her experience includes SPL electronic submissions, eCTD submissions across multiple regulatory agencies, establishment registration and product reporting, and regulatory requirements affecting human drugs and biologics. She also has extensive experience supporting companies with FDA user fee requirements, including GDUFA and OMUFA. Melissa earned a Bachelor of Science in Chemistry and then pursued her Master of Sciences.