Overview
Carly counsels domestic and international clients on regulatory compliance related to food and drug matters, with an emphasis on food additives, food-contact materials, and drug packaging. She advises companies on efficient ways to establish a suitable regulatory status for their products, and assists in obtaining regulatory clearances for food additives and food-contact materials in jurisdictions throughout the world, including the United States, Canada, China, the European Union (EU), and MERCOSUR. Carly also assists clients with the filing of Drug Master Files with the US Food and Drug Administration (FDA) and Health Canada. Her experience includes representing clients on litigation matters that particularly involve challenging technical and scientific issues.
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.
Carly was a law clerk for the Hon. Robert D. Mariani of the US District Court for the Middle District of Pennsylvania, where she drafted opinions and orders addressing various pre- and post-trial motions in civil and criminal matters, prepared materials for trials, hearings and oral arguments, and conducted legal research.
- District of Columbia
- Maryland
- Hon. Robert D. Mariani, US District Court, Middle District of Pennsylvania, 2020-2021
- J.D., Syracuse University College of Law, 2020, magna cum laude; Order of the Coif; Associate Notes Editor, Syracuse Law Review; Appellate Division Member of the Travis H.D. Lewin Advocacy Honor Society
- B.S., Hobart and William Smith Colleges, 2015, Chemistry and Environmental Studies
News & Publications
Client Alerts
FDA Publishes Final Rule Revising Bases and Procedures for Revoking FCN Authorizations
March 22, 2024
By: Joan Baughan, Daniel C. Rubenstein, Joseph Dages, Carly Rolph
Client Alerts
State of the States: PFAS Food Packaging Bans and Restrictions
December 29, 2022
By: Joan Baughan, Joseph Dages, Jessica Cooper, Ph.D., Carly Rolph
Events
Seminars & Events
Complimentary Food Contact Conference
April 23, 2024 - April 24, 2024
Speakers: Joan Baughan, Daniel C. Rubenstein, Joseph Dages, Carly Rolph, Kimberly Cassidy, Ph.D., Jessica Cooper, Ph.D., Patricia Kinne, Tom Gillett, Ruxandra Cana, Daniel Blynn, Anthony G. Hopp, Surya Kundu, Dr. Yan Gu
Keynote Speakers: Dr. Paul Honigfort, Dr. Zhu Lei
Seminars & Events
Complimentary Food Contact Conference
April 25, 2023 - April 26, 2023
Speakers: Joan Baughan, Daniel C. Rubenstein, Joseph Dages, Carly Rolph, Kimberly Cassidy, Ph.D., Jessica Cooper, Ph.D., Patricia Kinne, Glen Rosini, Tom Gillett, Anthony G. Hopp, Ruxandra Cana, Coy Garrison, Abigail Miller, Regulatory Review Chemist, US Food and Drug Administration (FDA), Sean Fischer, Consumer Safety Officer, US Food and Drug Administration (FDA), Daniel Felton, Executive Director, AMERIPEN