Email address
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+1 202 239 3300Provided by Chambers
Alston & Bird LLP offers a wealth of expertise in FDA enforcement and compliance matters, with broad cross-border capabilities. The firm is noted for advising drug manufacturers on a range of issues including warning letters, HIPAA and fraud and abuse matters. It also counsels on compliance issues in new product developments.
Provided by Chambers
Alston & Bird provides concise, timely, practical legal advice. The firm reacts quickly to requests and provides a high-quality work product.
The firm offers pragmatism, responsiveness, a sense of urgency and a solutions-driven approach. I can rely on it to provide advice that makes me feel confident we are being compliant and ethical.
The team has extensive knowledge of FDA and its statutes and regulations, but what really sets them apart is their technical and strategic acumen.
The firm has long and varied experience, paired with deep understanding of the FDA's expectations and interpretation of regulations and guidance.
Alston & Bird provides concise, timely, practical legal advice. The firm reacts quickly to requests and provides a high-quality work product.
The firm offers pragmatism, responsiveness, a sense of urgency and a solutions-driven approach. I can rely on it to provide advice that makes me feel confident we are being compliant and ethical.
The team has extensive knowledge of FDA and its statutes and regulations, but what really sets them apart is their technical and strategic acumen.
The firm has long and varied experience, paired with deep understanding of the FDA's expectations and interpretation of regulations and guidance.
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.
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.
Heidi Sorensen of Alston & Bird LLP advises a variety of clients, including healthcare providers, on regulatory compliance and government investigations.
I value Heidi's straightforward and practical approach to managing expectations. She has very strong expertise and a high degree of credibility.
Joyce is a remarkable individual who combines exquisite policy expertise, keen political insights, and unflappably strong client engagement.
Joyce is a pleasure to work with; she makes herself readily available and is incredibly responsive. She is pragmatic and solutions-oriented.
Marc Scheineson of Alston & Bird LLP is recognized for his healthcare regulatory practice focused on providing FDA regulatory compliance guidance to a range of pharmaceutical, medical device and biotech clients.
Marc has always been terrific to work with. His level of expertise is exceptional.
Brendan is a seasoned professional whose deep technical abilities could make you think he had pharmaceutical operational experience.
Brian Lee of Alston & Bird LLP is an up-and-coming attorney who assists clients with regulatory matters. He also has experience in Medicare reimbursement.
Brian has deep expertise on CMS guidelines, regulations and benefit design.
Anthony Fanucci of Alston & Bird LLP is an associate noted for his regulatory practice which sees him assist pharmaceutical clients with FDA regulatory guidance and actions.