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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.
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, 2023 FDLI Distinguished Service and Leadership Award recipient.
FDLI’s “How to Comply with Drug CGMPs,” now in its third edition.
Provided by Chambers
Cathy Burgess of Alston & Bird LLP is a highly regarded regulatory practitioner with strong experience in the pharmaceutical and medical products sector. She has further experience in FDA inspections and internal investigations.
Provided by Chambers
Cathy is an outstanding attorney that supervises an outstanding team.
Cathy has deep domain knowledge, both from an FDA standpoint and the GMPs. Cathy is extremely responsive, fact-based, reliable, honest and straightforward.
Cathy is an outstanding attorney that supervises an outstanding team.
Cathy has deep domain knowledge, both from an FDA standpoint and the GMPs. Cathy is extremely responsive, fact-based, reliable, honest and straightforward.
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).