Dr. Suleman’s experience at FDA in CDRH and CDER, in addition to his expertise in medical physics, nuclear medicine, and radiology, will be valuable to our clients developing and seeking market approval for radiation products and therapies.
ROCHELLE, Va. (PRWEB)
April 15, 2020
NDA Partners Chairman Carl Peck, MD, announced today that Orhan H. Suleiman, MS, PhD, FAAPM, FHPS, former Senior Science Policy Advisor with the Center for Drug Evaluation and Research and former Branch Chief of Radiation Programs and Radiology Devices in the Center for Devices and Radiological Health, has joined the firm as an Expert Consultant.
Dr. Suleiman has expertise in health physics, medical physics, nuclear medicine, radiology, and radiation products and therapies, with 42 years of experience with state and federal governments, including 37 years at the FDA. He served as Branch Chief in CDRH, Senior Science Policy Advisor in the FDA Office of the Commissioner’s Office of Counter-terrorism, and Senior Science Policy Advisor in CDER, where he was involved in the regulatory review and approval of medical device and pharmaceutical products, safety, human subject research, and inspections. He also represented the FDA on a variety of national and international committees, including the US Nuclear Regulatory Commission’s (NRC) medical isotope committee for over 10 years. Prior to his FDA career, he served as a Health Physicist in the United States Army Environmental Hygiene Agency (USAEHA).
According to Dr. Peck, “Dr. Suleiman’s experience at FDA in CDRH and CDER, in addition to his expertise in medical physics, nuclear medicine, and radiology, will be valuable to our clients developing and seeking market approval for radiation products and therapies. We are very pleased that he has joined NDA Partners.”
Dr. Suleiman earned a doctorate in environmental health sciences (medical physics) from Johns Hopkins University and a master’s degree in zoology and radiological sciences from the University of Florida. He is an Emeritus member of the FDA’s Senior Biomedical Research Service (SBRS), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Fellow of the American Association of Physicists in Medicine (AAPM), and Fellow in the Health Physics Society. He has served on numerous scientific committees, authored over 50 published articles in the scientific literature, and presented domestically and internationally on biomedical research, health physics, nuclear medicine, and molecular imaging.
About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Earle Martin, Chief Executive Officer
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Published at Wed, 15 Apr 2020 00:00:00 +0000