Chambers Review

Provided by Chambers
Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia
4
Band 4
What the team is known for

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.

Work Highlights

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.

Strengths

Provided by Chambers

Notable Practitioners

Provided by Chambers
Cathy Burgess
2
Cathy Burgess
2
Band 2

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
5
Heidi Sorensen
5
Band 5

Heidi Sorensen advises a variety of clients, including healthcare providers, on regulatory compliance and government investigations.

"Heidi is incredibly knowledgeable."

Joyce Gresko
5
Joyce Gresko
5
Band 5

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
U
Brendan Carroll
U
Up and Coming

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."

Ranked Lawyers at
Alston & Bird LLP

Provided by Chambers
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Band

District of Columbia

Healthcare

Heidi Sorensen
5
Heidi Sorensen
5
Band 5
Joyce Gresko
5
Joyce Gresko
5
Band 5
Healthcare: Pharmaceutical/Medical Products Regulatory

Cathy Burgess
2
Cathy Burgess
2
Band 2
Brendan Carroll
U
Brendan Carroll
U
Up and Coming