Attorney Jessika Tuazon advises health care and life sciences organizations and investors on a broad range of operational, regulatory, and enforcement issues. When clients need help navigating their complex and evolving regulatory landscape, they turn to Jessika for strategic counsel and guidance on managing and mitigating risks.
Her clients include manufacturers and distributors of drugs, medical devices, food, dietary supplements, cosmetics, combination products, contract research organizations, and digital health companies.
Investors and private equity firms that invest in health care and life sciences companies also rely on Jessika. She assists with all aspects of health regulatory due diligence, including the post-transaction transition of quality and regulatory operations. Clients rely on her extensive experience in federal and state health regulatory license and permit requirements, including changes of ownership and resolution of compliance issues and enforcement actions.
Jessika counsels medical device and pharmaceutical manufacturers on premarket clearance and approval strategies, including preparing and advising on premarket submissions to the U.S. Food and Drug Administration. These companies also turn to Jessika for assistance in understanding advertising and promotional risks related to their product labeling and promotional materials and developing compliant marketing strategies that align with business objectives. In addition, she counsels clients on a wide variety of regulatory and compliance issues applicable to manufacturing, clinical research, and distribution.
Before joining Epstein Becker Green, Jessika was a food, drug, and life sciences attorney at a law firm in Miami. While attending law school, she was a Law Clerk in the General Counsel’s office of the Florida Agency for Health Care Administration, where she advised senior attorneys on issues of compliance with state licensure and operational requirements. She also served as a legal intern for a civics and leadership-focused nonprofit organization, where she spearheaded revisions to the organization’s governance structure and related compliance policies.
- Digital Health
- Drug and Medical Device Distribution
- FDA Inspections and Enforcement
- Fraud and Abuse Compliance Counseling and Defense
- Health Care
- Industry Research and Clinical Trials
- Life Sciences
- Life Sciences Due Diligence
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
- Performed numerous health regulatory diligences for private equity clients that invest in health care and life sciences companies, including recent transactions involving pharmaceutical and medical device manufacturers, contract research organizations, food and dietary supplement manufacturers, home infusion pharmacies, wholesale drug and medical device distributors, and start-up digital health technologies.
- Supported a medical device company’s post-transaction integration efforts, including the global transition of quality and regulatory operations, the transfer of facility- and product-related licensure and registrations, and the negotiation of various business and quality agreements.
- Counseled an active pharmaceutical ingredient manufacturer on state licensure requirements applicable to its operations.
- Advised a drug and medical device company on regulatory and compliance risks related to its advertising and promotional materials, including a comprehensive review of the company’s website and testimonials.
- Provided counsel to a hospital on various regulatory and contract issues related to an affiliated pharmacy’s receipt of, and response to, a FDA warning letter.
- Serves as legal counsel to the Combination Products Coalition, a group of leading pharmaceutical, device, and biologics manufacturers focused on regulatory issues impacting combination products.
- University of Miami School of Law (J.D., 2012)
- University of Southern California (B.A., magna cum laude, 2009)
Professional & Community Involvement
- American Bar Association
- ABA Food, Cosmetics, and Nutraceuticals Committee, Website Content Editor