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Provided by Cathy Burgess
FDA-regulated entities benefit from Cathy’s common-sense advice for achieving business objectives that avoid compliance and enforcement risks. With more than 30 years of extensive experience in the areas of CGMP regulation and product risk management, she has provided strategic counseling and works with clients to identify and address potential risks throughout the product life cycle. She focuses her practice on regulatory compliance, product risk management, enforcement, and policy matters affecting industries regulated by the FDA. Cathy is the co-author of FDLI’s “How to Comply with Drug CGMPs,” now in its third edition.
Food and Drug Law Institute, board of directors (2018-2022); Food and Drug Law Institute, Audit Committee, in-house training team to FDA; Parenteral Drug Association; Food and Drug Law Institute, 2024 FDLI Distinguished Service and Leadership Award recipient.
Provided by Chambers
Cathy Burgess is a highly regarded regulatory practitioner with strong experience in the pharmaceutical and medical products sector.
Provided by Chambers
"Cathy is extremely knowledgeable, experienced and very thorough."
"It is always a pleasure to work closely with Cathy."
"Cathy is extremely knowledgeable, experienced and very thorough."
"It is always a pleasure to work closely with Cathy."
1 item provided by Alston & Bird LLP
Alston & Bird Adds Former FDA Associate Chief Counsel Alexandra Marzelli as Counsel in Washington
Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA).
Alston & Bird Adds Former FDA Associate Chief Counsel Alexandra Marzelli as Counsel in Washington
Alston & Bird has expanded its health care and life sciences regulatory and compliance capabilities with the addition of counsel Alexandra Marzelli, former associate chief counsel at the U.S. Food and Drug Administration (FDA).
