Life Sciences Law Update
Gabrielle Simeck
Associate Global Regulatory
Languages
English
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Overview
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Experience
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Credentials
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Insights and events
Gabrielle Simeck advises pharmaceutical and biotechnology companies throughout the product life cycle on how to navigate the regulatory landscape and ensure compliance with statutory and regulation requirements.
Gabrielle regularly counsels on issues related to advertising and promotion, state licensure, and good manufacturing practice requirements.
Gabrielle maintains an active pro bono practice, including representating asylum clients and incarcerated clients seeking ADA accommodations and clemency. While at the University of Michigan Law School, Gabrielle participated in the Pediatric Advocacy Clinic and the Child Welfare Advocacy Clinic and enjoys advocating for and working with children as part of her pro bono practice.
Representative experience
Advise pharmaceutical companies on pre-approval and post-market promotional issues
Counsel manufacturers on issues related to drug substance compounding
Conduct audits and investigations related to good manufacturing practice requirements
Co-represented a family of undocumented immigrants in their appeal before the Board of Immigration Appeals
Represented a transgender woman in her affirmative asylum case
Credentials
Education
- Juris Doctor, University of Michigan Law School, 2023
- A.B. Political Science, St. Olaf College, Phi Beta Kappa, Summa Cum Laude, with Distinction in Political Science, 2018
Bar admissions and qualifications
- District of Columbia