Ryan D’Souza counsels domestic and international clients on regulatory compliance matters related to food and drug law, with an emphasis on food, drug, and medical device packaging. He advises companies on how to obtain regulatory clearances for food contact materials in jurisdictions throughout the world, including the United States (U.S.), Canada, and the European Union (EU). Ryan also assists clients with the filing of Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA) and Health Canada.
Ryan drafts legal opinion letters evaluating the regulatory compliance of packaging materials, including polymers, additives, printing inks, adhesives, and coatings, as well as color additives used in plastics, paper, and paperboard. He also counsels clients on good manufacturing practice (GMP) issues related to the manufacture of food packaging. In the area of sustainability, Ryan advises clients on regulatory requirements applicable to recycling processes and the use of recycled materials in packaging.
Ryan has a background in physiology and neurobiology and experience researching scientific, legal, and policy issues related to the pharmaceutical industry. Prior to joining Keller and Heckman, Ryan worked at a regulatory life science company where he provided research and analytical support on drug, tobacco, and dietary supplement submissions to FDA. His scientific background is valuable in assisting clients with technical aspects of food and drug law matters, such as determining the appropriate data needed to support submissions to FDA and other comparable international agencies. During law school, Ryan was a Legal Writing Fellow, Research Assistant in the UMB Center on Drugs and Public Policy, the Senior Articles Editor for the Journal of Health Care Law and Policy, and a Legal Affairs Intern at a pharmaceutical company.
Representative Matters
- Provided counsel and support in obtaining Food Contact Notifications (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
- Performed regulatory reviews of food contact materials to assess compliance with U.S. and EU food-contact laws and regulations
- Counseled clients on securing a suitable regulatory status for food contact materials marketed in the U.S. and EU
Memberships
- American Bar Association (ABA)
- University of Maryland Order of the Coif