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Christine Lentz

Christine Michel Lentz

Associate
About

Christine Lentz focuses her practice on FDA regulatory compliance, counselling clients that develop and commercialize FDA-regulated products, including drugs, biologics, medical devices, food and beverage, cosmetics, and dietary supplements. She also has experience navigating complex regulatory requirements that apply to products and services that are regulated by FTC, DEA, CMS, USDA, TTB, CPSC, and state licensing authorities.

Christine supports companies in managing multi-faceted regulatory issues across the product life cycle, from development to product launch and post market compliance, to defending government enforcement actions. In particular, she advises clients on state and federal licensing and registration, labelling requirements, advertising and promotion, as well as commercial agreements. Christine also leverages her regulatory expertise as a subject matter specialist on transactions, conducting due diligence on behalf of clients. 

In addition, Christine has experience advising life sciences, digital health, and medical device clients on a variety of health privacy, compliance, transactional, and litigation issues, including compliance with HIPAA and other laws that govern the collection, use, and disclosure of health information. She has conducted multijurisdictional surveys on the regulatory status of telehealth, corporate practice of dentistry, medical device manufacturing, and distribution, as well as analyses of laws and regulations surrounding healthcare fraud and abuse, anti-kickback, False Claims Act, contracting, Medicare and Medicaid reimbursement, state-law laboratory billing, and corporate practice of medicine.

 
Bar admissionsCalifornia

EXPERIENCE

Christine’s experience includes:

  • Advising on regulatory diligence and disclosure matters for public offerings, mergers and acquisitions, and private transactions involving regulated products and services
  • Drafting and reviewing annual and quarterly SEC filings of publicly traded life science companies Performing legal evaluation and risk assessment of labeling, packaging, advertising and promotional materials based on FDA and FTC requirements
  • Drafting commercial agreements for all levels of research and supply chain, including contract manufacturers and contract laboratories
  • Providing strategic guidance on FDA's premarket approval or clearance process, including assessment of applicable product classification
  • Counseling on state and federal permit and registration issues (FDA, DEA, TTB, CLIA, State Boards of Pharmacy, State Health Departments)
  • Serving as regulatory counsel in internal investigations for biotechnology companies involving allegations of GxP violations
  • Counseling companies on discrete regulatory issues ranging from human and animal subject research, to drug and biologic exclusivity and Sunshine Act reporting 
  • Evaluating legal and regulatory status of products and substances on the marketplace and providing strategic advice regarding proactive engagement with federal agencies
  • Serving as regulatory counsel for a global pharmaceutical company in federal court in a commercial contract dispute related to the FDA approval process of cell and gene therapy products
  • Drafting and submitting applications to federal and state regulators for commercial launch of new tobacco products
 
Languages
  • French
Education
  • J.D., University of San Diego School of Law
  • M.S., SKEMA Business School
  • B.S., A.B., University of California, Davis

Pro Bono

Christine’s pro bono work focuses on providing legal services to veterans through various clinics and outreach, as well as obtaining legal name changes for transgender individuals in conjunction with the USD Law Name and Gender-Marker Change Clinic.

Bylines

Seminars

  • Presenter, “FDA Regulatory & Strategy 101 Workshop,” Biocom California, October 29, 2024

Prior Experience

During law school, Christine worked full-time as a Research Analyst for an AmLaw50 firm where she also held positions as FDA and Life Science Compliance Extern, Corporate Legal Extern, and completed the Summer Associate Program.

Prior to law school, Christine held various roles within the patent and intellectual property research, management, and analytics sector. She also provided business development, marketing, and contract drafting support for a Contract Research Organization (CRO) offering molecular bioanalysis services to biopharmaceutical companies and research institutions.

 

Memberships and Affiliations

  • American Bar Association (ABA)
  • San Diego County Bar Association (SDCBA)
  • National Asian Pacific American Bar Association (NAPABA)
  • Pan Asian Lawyers of San Diego (PALSD)
  • San Diego Office Diversity and Inclusion Committee

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