Om Singh, PhD
Contact+1 202 828 8983 firstname.lastname@example.org
Dr. Om Singh is a Senior Scientific Consultant at TSG Consulting. He has substantial experience working with companies looking to commercialize medical devices and antimicrobial products such as sterilants, high-level disinfectants, and antiseptics. His previous experience working 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.
Dr. Singh relies on his scientific background in microbiology and deep understanding of regulatory approval pathways at FDA to benefit companies bringing their medical devices and antimicrobial products to market. 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 Investigational Device Exemption (IDE), 510(k) notifications for medical devices. Additionally, Dr. Singh’s hands-on experience with laboratory testing allows him to guide companies on standards and overall system requirements needed to demonstrate safety and efficacy.
B.S., Biological Science – Meerut University (India)
M.S., Zoology – Ch. Charan Singh University (India)
M.S., Regulatory Affairs in Life Sciences – The Johns Hopkins University
Ph.D., Microbial Biotechnology – Indian Institute of Technology (India)
Postdoctoral Fellow – The Johns Hopkins University School of Medicine