Department profile
Alston & Bird LLP

Healthcare: Pharmaceutical/Medical Products Regulatory

USA Guide 2026 : District of Columbia


Alston & Bird LLP

Rankings

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

Band 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

Provided by Chambers

  • Their support was really extraordinary, they hand-hold the colleagues in such a way that everybody feels they are part of our team.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • Alston & Bird is very knowledgeable in FDA-related matters and excels in providing the appropriate support and direction to the client.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • The team was very knowledgeable about the subject matter and provided relevant and timely advice.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • Alston & Bird distinguishes itself through its ability to truly step into our shoes and understand the regulatory and compliance risks holistically. It takes a strategic, business-oriented approach.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • The attorneys are extremely responsive and knowledgeable with experts in every subject we have ever needed. I have never had a compliance concern that they could not expertly address.

    Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

Notable Practitioners

Provided by Chambers

  • Band 1Cathy Burgess
    Band 1Cathy Burgess

    Cathy Burgess

    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.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Cathy is experienced in the field. Not only is she knowledgeable, but she is also very well connected.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Cathy is extremely knowledgeable and lends her expertise readily.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Cathy balances assertiveness with diplomacy in negotiations and acts as problem-solver under pressure.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Cathy is precise, attentive and extremely proactive in supporting our business needs.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • Band 4Heidi Sorensen
    Band 4Heidi Sorensen

    Heidi Sorensen

    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.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • Band 5Brendan Carroll
    Band 5Brendan Carroll

    Brendan Carroll

    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.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Brendan is super prompt in his responses, provides thoughtful guidance on whatever the challenges are and brings in diverse perspectives for conclusions.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • 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.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Brendan thinks strategically. He quickly understands the client's risks and presents practical options for resolution.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • Band 5Joyce Gresko
    Band 5Joyce Gresko

    Joyce Gresko

    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.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • 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.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
  • Band 5Marc J. Scheineson
    Band 5Marc J. Scheineson

    Marc J. Scheineson

    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.

  • Up and ComingBrian Lee
    Up and ComingBrian Lee

    Brian Lee

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

  • Associates to watchAnthony Fanucci
    Associates to watchAnthony Fanucci

    Anthony Fanucci

    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.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • I found Anthony to be knowledgeable, prompt and hard-working.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Anthony is extremely responsive and delivers the intended service.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Anthony is an excellent lawyer to work with. He has a high capacity for complex issues and is very responsive.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA
    • Anthony is technically very good. From his pharmacy background, he can understand what we are saying and help improve the quality of our response.

      Healthcare: Pharmaceutical/Medical Products Regulatory respondentUSA

Ranked Individuals at Alston & Bird LLP (7)

District of Columbia

Alston & Bird LLP has rankings in the following guides

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