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+1 202 239 3300Provided by Chambers
Offers a wealth of expertise in FDA enforcement and compliance matters, with broad cross-border capabilities. Noted for advising drug manufacturers on a range of issues including warning letters, HIPAA and fraud and abuse matters. Also counsels on compliance issues in new product developments.
Provided by Alston & Bird LLP
Alston & Bird advised Kimera Labs on compliance with the requirements of the FDA with respect to development, manufacture and marketing of exosome-based regenerative cell therapy.
Provided by Chambers
"Alston & Bird's group are excellent; they are client-focused, thoughtful and timely."
"The firm's bench is very deep, and the attorneys are able to quickly understand very complex regulatory matters. They always do an outstanding job."
"The team has a depth of knowledge."
"Alston & Bird's group are excellent; they are client-focused, thoughtful and timely."
"The firm's bench is very deep, and the attorneys are able to quickly understand very complex regulatory matters. They always do an outstanding job."
"The team has a depth of knowledge."
Provided by Chambers
Cathy Burgess is a highly regarded regulatory practitioner with strong experience in the pharmaceutical and medical products sector.
"Cathy is extremely knowledgeable, experienced and very thorough."
"It is always a pleasure to work closely with Cathy."
Heidi Sorensen advises a variety of clients, including healthcare providers, on regulatory compliance and government investigations.
"Heidi is incredibly knowledgeable."
Joyce Gresko advises healthcare providers, clinical laboratories and medical device manufacturers on a range of regulatory matters. She has notable experience of advising clients on fraud, waste and abuse issues, as well as labor and employment matters.
"Joyce is practical and tremendously hard-working."
Brendan Carroll offers significant experience of providing counsel on FDA regulation. He routinely advises clients on inspections, particularly in the manufacturing space.
"Brendan does an outstanding job."
"He is great to work with."
"He is responsive and provides practical advice."