Raafat Fahmy FDA

Dr. Raafat Fahmy has over 25 years experience in the pharmaceutical industry. For the past decade, Dr. Fahmy has served as a science advisor at the Food and Drug Administration and collaborated with the academia in several research programs. Dr. Fahmy provides leadership in the areas of drug product formulation, manufacturing and technology, including the evolving field of dissolution, formulations, manufacturing, and chemometric. He also works with other experts at the agency and other organizations to provide scientific expertise in the development of policies and guidance in the area of manufacturing processes. Dr. Fahmy represents FDA/CVM on manufacturing issues in national and international scientific symposiums.

Dr. Fahmy’s critical path research supports innovation and efficiency in pharmaceutical development, manufacturing, and quality control. His collaborative research projects with the University of Maryland School of Pharmacy enhances manufacturing science, improves the scientific basis for understanding the behavior of pharmaceutical materials and allows for the development of robust processes early in the development process. Dr. Fahmy has also authored several textbook chapters, articles, and scientific papers. His critical path research focuses on important regulatory issues such as quality by design and online process control, which have a positive impact on the regulated industry inside and outside the USA and the Agency.