Carly Rolph counsels domestic and international clients on regulatory compliance related to food and drug packaging materials, with an emphasis on food additives, food-contact materials, and drug packaging. She advises companies on how to obtain regulatory clearances for food-contact materials in jurisdictions throughout the world, including the United States, Canada, and the European Union (EU). Carly also assists clients with the filing of Drug Master Files with the U.S. Food and Drug Administration (FDA) and Health Canada.
Carly has a background in chemistry and biology with research experience that includes cell biology and organic chemistry. Her scientific background is valuable in assisting clients with technical aspects of regulatory work, such as determining the appropriate data needed to support new Food Contact Notification (FCN) submissions to the FDA.
While in law school, Carly was an Associate Notes Editor of the Syracuse Law Review and earned the CALI Excellence for the Future Award for Contracts, Constitutional Law II, European Union Law, and Immigration Law. She was an Appellate Division member of the Travis H.D. Lewin Advocacy Honor Society, Syracuse University’s version of moot court society, and was selected for membership in the Syracuse chapter of the Order of the Coif, as well as the Justinian Honor Society.
Prior to joining Keller and Heckman, she served as a law clerk to U.S. District Court Judge Robert D. Mariani of the Middle District of Pennsylvania.
(Admitted to practice in Maryland only. Practice limited to matters before the FDA and matters ancillary thereto.)
- Assisted clients in the recycled plastics industry in obtaining Letters of No Objection from FDA and Health Canada, confirming the capability of their recycling processes to produce post-consumer recycled material that is suitable for food-contact use
- Counseled clients on securing a suitable regulatory status for food-contact materials marketed in the U.S. and the EU
- Provided counsel and support in obtaining (FCNs) for food contact substances from the FDA