Seun Awotunde counsels domestic and international clients on regulatory and compliance matters related to food and drug packaging, medical devices, food additives and ingredients, dietary supplements, and pharmaceuticals. She advises clients with U.S. Food and Drug Administration (FDA) submissions, including food contact notifications (FCNs) and Drug Master Files (DMFs). She assists companies in obtaining food contact clearances for their products in Canada, Asia, South America, as well as the European Union (EU). She also has experience with premarket notifications for medical devices (510(k) notices) and investigational new drug applications (NDAs). 

Seun regularly drafts legal opinions for clients evaluating packaging components, including polymers, adhesives, printing inks, and color additives used in plastic, paper and paperboard, and coatings in various global jurisdictions. She also advises clients on establishing self-determined Generally Recognized as Safe (GRAS) positions in the United States and on regulatory requirements governing the use of recycled materials in food contact applications.

Prior to joining Keller and Heckman, Seun was an associate for a law firm where she represented pharmaceutical, biotechnology, and medical device companies. Her background in science and experience working in healthcare is valuable in assisting clients with technical aspects of regulatory work and in understanding and interpreting the complex scientific matters as they relate to legal and regulatory requirements.

While in law school, Seun was an Executive Board Member for the Howard Law Journal, in addition to serving as a teaching assistant. She also completed an internship for the U.S. Securities and Exchange Commission, Division of Enforcement and served as a Judicial Intern for the Honorable Reggie B. Walton on the United States District Court for the District of Columbia.

Representative Matters

• Provided counsel and support in obtaining FCNs for food contact substances from FDA
• Prepared legal opinion letters and submissions to FDA establishing the capability of recycling processes to produce post-consumer recycled material that is suitable for use in food contact applications
• Analyzed various commercial agreements (e.g., NDA, vendor agreements, service agreements) to identify potential contractual risks and business opportunities
• Completed diligence reports for corporate clients

Memberships

• Food & Drug Law Institute (FDLI)
• Washington Bar Association (WBA) 
• American Bar Association (ABA)