Om Singh, PhD

Senior Scientific Consultant


+1 202 828 8983

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

Professional Memberships

American Society of Microbiology (ASM), Member

American Association for the Advancement of Science (AAAS), Member

Haven't found what you were looking for?

Professionalsarrow pointing right

Our regulatory specialists and scientists address all aspects of product registration and ongoing compliance. Read more about the individuals who make up our multi-disciplinary teams.

Regulatory advicearrow pointing rightarrow pointing right

With offices throughout the US and Europe, we can help you with navigating the complex, global regulatory environment.