Healthcare: Pharmaceutical/Medical Products Regulatory | USA

Covington & Burling LLP is a powerhouse in the pharmaceutical and medical device industry with extensive experience advising on product development, manufacturing and pharmacovigilance. The firm is retained by clients for its proficiency dealing with regulatory bodies, including the FDA and Consumer Product Safety Commission.

Arnold & Porter is an impressive team with wide-ranging expertise in healthcare, pharmaceutical and medical device matters, including innovative technology and compliance issues. Integrated life sciences practice offers strong IT services to clients, alongside FDA and healthcare regulatory compliance counseling. Notable litigation capabilities include both civil and criminal defense work. Offers strength acting for organizational as well as individual clients in the healthcare space.

Latham & Watkins' team advises a wide range of healthcare entities, including hospitals, laboratories and distributors, on complex investigations and transactions. Its interdisciplinary approach offers clients varied expertise in areas such as qui tam litigation and capital markets investment. The firm also acts on administrative challenges and FDA regulatory issues. The team's clients additionally include companies in the pharmaceutical, medical device manufacturing and biotech industries.

Ropes & Gray LLP has a robust practice sought after for a range of matters spanning healthcare, medical device and pharmaceutical issues. The team offers substantial experience in regulatory issues including compliance and investigations work, coupled with pharmaceutical expertise encompassing advertising and patent advice. It is also noted for arguing cases in trial and appellate courts.

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.

Goodwin counsels a broad range of clients including pharmaceuticals and medical device manufacturers on complex FDA regulatory issues. Noted for its significant expertise in compliance related to new drug and device development and its strong cross-border capabilities. Also acts on transactions such as the sale of drug rights.

Morgan, Lewis & Bockius LLP demonstrates extensive capabilities in health law compliance matters, including investigations and other regulatory challenges. Attracts a broad roster of clients, including healthcare service providers, pharmaceutical and biotech companies. Frequently acts on civil and criminal litigation, as well as representing private equity firms in high-value healthcare acquisitions. Offers notable expertise in advising on complex coverage and reimbursement issues. Also noted for its FDA regulatory capabilities.

Akin is a strong force in the healthcare market that acts for multiple high-profile clients. The team excels across the range of regulatory and litigation work, regularly representing clients in investigations and disputes with government bodies. Its expertise includes Medicare reimbursement disputes and False Claims Act claims. The group also possesses experience advising healthcare clients on due diligence and other aspects of transactional matters.

ArentFox Schiff LLP is a strong team noted for its handling of wide-ranging matters, including regulatory compliance, external investigations and litigation. Particularly adept at fraud and abuse matters, with significant expertise in high-stakes False Claims Act matters. Also offers experience in drug pricing and FDA regulatory issues for pharmaceutical and medical device companies.

BakerHostetler LLP has notable experience in high-profile FDA mandates. Regularly advises pharmaceutical clients and providers as well as private equity funds on regulatory issues such as those connected to new drug applications and advertising matters. Expertise in negotiating pharmacy benefit management contracts. Also offers strong skills in a broad range of transactions including sale of assets and joint ventures.

McDermott Will & Emery is a premier group with diverse subject matter expertise, handling complex transactional and regulatory matters for an enviable client list. The firm represents a range of clients, notably healthcare providers and private equity firms, across the full spectrum of healthcare work, including lobbying and policy matters. It regularly advises on civil litigation and high-stakes enforcement proceedings. The team's expertise extends to FDA regulatory compliance.

Reed Smith LLP has an excellent healthcare team that maintains a strong profile for regulatory work, including reimbursement and transactional due diligence. Regularly advises care providers, investors and new technology manufacturers, among others. Experience includes advising on external investigations conducted by government bodies such as the DOJ. Also counsels pharmaceutical and medical device manufacturers on FDA regulation and fraud and abuse matters.

Skadden, Arps, Slate, Meagher & Flom LLP & Affiliates is a well-regarded team offering knowledge across a broad range of industry concerns. Provides high-level advice on regulatory compliance and enforcement proceedings. Noted for strength in both civil and criminal litigation, and also draws on significant transactional capabilities. Acts for a range of life sciences companies alongside providers, fielding increasing strength in FDA regulatory issues. Also noted for its handling of issues arising from the opioid sector.

Cooley LLP is recognized for its robust practice, providing FDA-related regulatory advice for a range of clients in the healthcare sphere, including pharmaceutical companies, medical device companies and digital health companies. It is also sought out for other regulatory, legal and compliance support in the life sciences space.

McGuireWoods LLP is noted for its healthcare regulatory and compliance practice. It has particular expertise in assisting pharmaceutical companies with FDA regulations, including with regulatory actions and licensing and production matters.

Polsinelli has a significant healthcare practice. The practitioners are routinely called upon to assist with FDA regulatory issues. The team is noted for its representation of medical device manufacturers in a range of issues, and is adept at handling matters related to HIPAA compliance, data privacy and security, as well as Medicare coverage and payment issues.