Komal Karnik Nigam
Counsel Global Regulatory
Languages
English, Hindi, Spanish
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Overview
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Experience
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Credentials
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Insights and events
As counsel in our FDA Pharmaceuticals and Biotechnology group, Komal Karnik Nigam uses her background in public health and scientific research to understand the business and policy aspects of complex legal and scientific issues in the pharmaceutical industry.
Her practice includes a broad range of regulatory matters, including assisting pharmaceutical clients with lifecycle management and product development issues, regulatory due diligence for drug company mergers and acquisitions, and responses to FDA enforcement actions and related government investigations. She routinely advises pharmaceutical companies on advertising and promotion issues and has served on multiple promotional review committees. In her pro bono practice, she has successfully represented clients in asylum and special immigrant juvenile status cases.
Komal received her J.D., M.P.H. through the joint-degree program at Harvard Law School and the Harvard T.H. Chan School of Public Health. Komal previously worked as a research assistant in a molecular biology laboratory at the University of Virginia, where she learned how to parse abstract scientific language and communicate it to others. She has also worked in advocacy positions at nonprofit public interest and public health organizations in Waltham, Massachusetts and in Washington, D.C.
Representative experience
Counsel numerous pharmaceutical companies on pre-launch and post-marketing Commercial and Medical Affairs activities, including extensive experience on promotional review committees.
Citizen petition regarding issues raised by an Abbreviated New Drug Application for a generic topical product that differed from the reference product.
Assist multiple pharmaceutical companies in responding to FDA enforcement letters, Form FDA 483 inspectional observations, and related government investigations.
Represent multiple pharmaceutical companies in formal dispute resolution before FDA regarding issues arising from stalled clinical trial programs
Successfully advocate for small business waiver of Prescription Drug User Fee Act fees for biotechnology company with external shareholders and venture capital funding
Credentials
- J.D., Harvard Law School, cum laude, 2014
- M.P.H., Harvard School of Public Health, 2014
- B.A., University of Virginia, with distinction, 2011
- District of Columbia
- Virginia
- U.S. District Court, Eastern District of Virginia
- South Asian Bar Association
- National Asian Pacific American Bar Association