Overview

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.

Read more

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.

Read less

Focus Areas

Experience

View All Experience
  • 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.

Recognition

Credentials

Education

  • University of Miami School of Law (J.D., 2012)
  • University of Southern California (B.A., magna cum laude, 2009)

Bar Admissions

  • California
  • Florida

Professional & Community Involvement

  • American Bar Association
    • ABA Food, Cosmetics, and Nutraceuticals Committee, Website Content Editor

Media

Events

Insights

View All Insights

Insights

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.