Shruti R. Kulkarni, Esq.

Associate

202-580-8070


Bar Admissions

  • District of Columbia
  • Maryland

Education

Ms. Kulkarni provides counsel to pharmaceutical, biotechnology, and medical device companies. She offers insight on federal and state legal, legislative, regulatory, and enforcement matters. In this capacity, she has analyzed existing and proposed legislation, regulation, and policies; drafted legislative and regulatory language, testimony, and white papers; and educated state and federal legislators and policy makers.

Ms. Kulkarni has more than 10 years of experience in the health care industry, including working for pharmaceutical companies in government affairs and sales positions. Immediately prior to joining the firm, she completed a legal internship at the U.S. Food and Drug Administration’s Office of Policy in the Office of the Commissioner where she provided input on First Amendment-related matters; and worked on Food Safety Modernization Act’s Proposed Rule for Produce Safety.

Ms. Kulkarni obtained her Juris Doctor degree from George Mason University School of Law, where she served as a Writing Fellow, teaching first year law students legal research, writing, and analysis. She also served on the school’s Moot Court Board and represented the school on the Moot Court Board’s National Team. She received her bachelor’s degree magna cum laude from Saint Joseph’s University.

  • Shruti R. Kulkarni, et al.What’s in a Number? Recommending Practicality in the DATA 2000 Patient Limits, 12 J. Opioid Manag. 243 (2016).
  • National Sheriffs’ Association
    June 16, 2019
    Louisville, KY
    “Innovative Law-Enforcement Led Programs to Reduce the Overdose Epidemic”
    Presenter
  • International Conference on Opioids
    June 9 – 11, 2019
    Boston, MA
    “Finding Your Footing in an Ever Changing Landscape: A Legal, Regulatory, and Public Health Update”
    Presenter
  • ACI Controlled Substances Summit
    May 29 – 30, 2019
    Washington, DC
    “Understanding the Implications of the National Policy Response to the Opioid Overdose Crisis”
    Presenter
  • Rx Drug Abuse & Heroin Summit
    April 22 – 25, 2019
    Atlanta, GA
    “Opioid Use Disorder Interventions and Treatment in Jails: Policy and Practice”
    Presenter
  • National Foundation for Women Legislators Annual Conference
    November 14, 2018
    Washington, DC
    “Doctors in Distress: Avoiding Health Care Provider Shortages”
    Presenter
  • National Association of State Controlled Substances Authorities Annual Conference
    October 31, 2018
    “Gender Differences and Substance Abuse: Eliminate Discrimination, Improve Treatment and Save Lives”
    Presenter
  • 5th Annual Human Abuse and Liability Summit
    November 6, 2018
    Correct for Gender-Based Disparities in Drug R&D and Law Enforcement
    Presenter
  • International Conference on Opioids
    June 10, 2018
    Boston, MA
    “Warm Handoff: Bridging the Gap Between Overdose and Treatment”
    Presenter
  • National Rx Drug Abuse and Heroin Summit
    April 22-25, 2018
    Atlanta, GA
    “Gender Differences and Substance Abuse: Eliminate Discrimination, Improve Treatment and Save Lives”
    Presenter
  • National Sheriffs’ Association
    February 11, 2018
    Washington, D.C.
    “Warm Handoff: Bringing the Gap Between Overdose and Treatment”
    Presenter
  • ACI’s Legal, Regulatory, & Compliance Forum on Controlled Substances
    January 29, 2018
    Washington, D.C.
    “Politics and Policy of Controlled Substances in View of the Opioid Overdose Crisis”
    Presenter
  • Abuse Deterrent Formulations Critical Update
    December 7, 2017
    Philadelphia, PA
    “Legislative Initiatives Addressing the Opioid Epidemic”
    Presenter
  • National Criminal Justice Association
    July 30, 2017
    Long Beach, California
    “Innovative Law Enforcement-Led Programs Save Lives”
    Presenter
  • Metropolitan Washington Council of Governments
    May 9, 2017
    Washington, D.C.
    “Gender Differences and Substance Use Disorders: Eliminate Discrimination, Improve Treatment, and Save Lives”
    Presenter
  • National Rx Drug Abuse and Heroin Summit
    April 18-19, 2017
    Atlanta, GA
    “Wielding Women’s Influence To Eliminate Stigma, Improve Health Care, and Save Lives”
    Presenter
    “Save Lives, Save Costs: Help Law Enforcement Reduce the Opioid Overdose Epidemic”
    Presenter
  • Abuse-Deterrent Formulations Summit
    March 7, 2017
    Alexandria, Virginia
    “Aligning Market Objectives and Policy for National Public Health”
    Presenter
  • National Sheriffs’ Association
    February 5, 2017
    Washington, D.C.
    “Shift in Community Policing: Sheriffs’ Innovative Substance Use Programs to Save Lives and Dollars”
    Presenter