Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

3
Band 3

What the Team is Known For

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.

Strengths

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Notable Practitioners

Provided by Chambers

Cathy Burgess
1
Cathy Burgess
1
Band 1

Cathy Burgess 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.

I think Cathy is top-notch. She has a good understanding of regulatory issues and is very prompt in her responses.

Cathy is experienced in the field. Not only is she knowledgeable, but she is also very well connected.

Cathy is extremely knowledgeable and lends her expertise readily.

Cathy balances assertiveness with diplomacy in negotiations and acts as problem-solver under pressure.

Cathy is precise, attentive and extremely proactive in supporting our business needs.

Heidi Sorensen
4
Heidi Sorensen
4
Band 4

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

Heidi totally understands our issues and is able to guide us in a way that brings us comfort and helps us make the right decisions.

Brendan Carroll
5
Brendan Carroll
5
Band 5
Brendan Carroll offers significant experience of providing counsel on FDA regulation. He routinely advises clients on inspections, particularly in the manufacturing space.

Brenden is fantastic. He has a great knowledge of our industry and is just wonderful to work with.

Brendan is super prompt in his responses, provides thoughtful guidance on whatever the challenges are and brings in diverse perspectives for conclusions.

Brendan is a hard worker, he goes through everything, makes sure he is on top of all the things he is doing and is a cool and level-headed person.

Brendan thinks strategically. He quickly understands the client's risks and presents practical options for resolution.

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 an outstanding adviser.

She is an expert about working on lab-related issues from compliance, billing, reimbursement and healthcare policy. Joyce is responsive and available and is practical on guidance she gives.

Marc J. Scheineson
5
Marc J. Scheineson
5
Band 5

Marc Scheineson is recognized for his healthcare regulatory practice focused on providing FDA regulatory compliance guidance to a range of pharmaceutical, medical device and biotech clients.

Brian Lee
U
Brian Lee
U
Up and Coming

Brian Lee is an up-and-coming attorney who assists clients with regulatory matters. He also has experience in Medicare reimbursement.

Anthony Fanucci
Anthony Fanucci
Associates to watch

Anthony Fanucci is an associate noted for his regulatory practice which sees him assist pharmaceutical clients with FDA regulatory guidance and actions.

Anthony is a talented writer with a sharp mind for critical thinking.

I found Anthony to be knowledgeable, prompt and hard-working.

Anthony is extremely responsive and delivers the intended service.

Anthony is an excellent lawyer to work with. He has a high capacity for complex issues and is very responsive.

Anthony is technically very good. From his pharmacy background, he can understand what we are saying and help improve the quality of our response.

Ranked Lawyers at
Alston & Bird LLP

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District of Columbia

Healthcare

Heidi Sorensen
4
Heidi Sorensen
4
Band 4
Joyce Gresko
5
Joyce Gresko
5
Band 5
Brian Lee
U
Brian Lee
U
Up and Coming
Healthcare: Pharmaceutical/Medical Products Regulatory

Cathy Burgess
1
Cathy Burgess
1
Band 1
Brendan Carroll
5
Brendan Carroll
5
Band 5
Marc J. Scheineson
5
Marc J. Scheineson
5
Band 5
Anthony Fanucci
Anthony Fanucci
Associates to watch