Shilpa Prem

Shilpa Prem

Senior Associate, Philadelphia

Email shilpa.prem@​

Phone +1 267 675 4682

Fax +1 267 675 4601

Practice groupRegulatory

Shilpa Prem understands the high-pressure business environment of the regulated medical device industry. She represents clients in Food and Drug Administration (FDA) medical device approval and clearance associated matters.

She conducts regulatory due diligence for medical device manufacturers in mergers and acquisitions, joint ventures, and private equity/venture capital investments deals. Shilpa also drafts trade complaints and assists medical device and health care technology companies in navigating matters related to FDA regulation, including current good manufacturing practices and quality systems, postmarket surveillance and safety reporting, recalls, warning letter responses, and advertising- and promotion-related matters.

Shilpa brings significant industry experience to the firm, having held senior roles in leading medical device companies. During law school, she was a principal regulatory affairs associate and graduated with a Health Law concentration with distinction and honors. She is a bioengineer by training and has published papers in leading orthopedic peer-review journals, such as the Journal of Spinal Disorders and Spine.

Education and admissions


J.D., Suffolk University Law School, cum laude, 2014

M.A., Harvard University, 2012

B.S., Oregon State University, 2006

Bar admissions and qualifications


New York

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