TSG Hires Dr. Om Singh
Dr. Om Singh has joined TSG as a Senior Scientific Consultant. Dr. Singh advises companies looking to commercialize medical devices and antimicrobial products such as sterilants, high-level disinfectants, and antiseptics. His previous experience at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) allows him to better advise companies of anticipated regulatory hurdles when seeking approval and registration for their human health products.
He has particular expertise clarifying the regulatory jurisdiction of human health products, identifying predicates that may be used to demonstrate substantial equivalence (SE), reviewing studies and data requirements, and submitting 510(k) notifications for medical devices. Additionally, his hands-on experience with laboratory testing allows him to guide companies on standards and overall system requirements needed to demonstrate safety and efficacy.
Dr. Singh received his M.S. in Regulatory Affairs in Life Sciences from Johns Hopkins University and his Ph.D. in Microbial Biotechnology from the Indian Institute of Technology. He was also a postdoctoral fellow at Johns Hopkins School of Medicine.