Panoramic: Automotive and Mobility 2025
Regulatory Inspections and cGMP
We are recognized internationally for our FDA regulatory experience, including a seasoned team devoted to FDA compliance, with a particular focus on drug current good manufacturing practice (GMP).
We have almost 30 lawyers devoted to pharmaceutical regulation, many of whom worked at FDA before joining Hogan Lovells, a number with extensive experience handling GMP enforcement, both while at FDA and at the firm. Our GMP practice is truly global, and our team is regularly onsite providing clients with real-time support at manufacturing facilities around the world.
We also have negotiated many GMP- related consent decrees with FDA, and defend criminal prosecutions of companies and executives under the Park doctrine.
We combine a breadth and depth of practice, industry and technical knowledge, and geographical reach to provide creative, practical and business-oriented advice and representation on the issues that affect our clients most deeply, and to efficiently marshal and coordinate resources across borders.
Our capabilities at a glance
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Judicial review wins
2
Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Representative experience
Advised multiple clients on drug shortage and supply chain disruption due to export bans of certain medicinal products due to the COVID-19 pandemic.
Provided onsite FDA inspection and GMP/data integrity support to manufacturing sites around the world, including in the United States, China, India, Japan, Europe, and South America.
Helped pharmaceutical companies, large and small, around the globe successfully resolve Form FDA 483 observations and Warning Letters.
Conducted privileged investigations of alleged significant GMP compliance and data integrity deviations.
Successfully assisted companies and individual defendants in vacating GMP consent decrees.
Provided regulatory and white-collar investigation support to pharmaceutical companies in responding to qui tam (whistleblower) actions involving GMP and data integrity allegations.
Helped develop and implement GMP policies and procedures and related training.
Developed briefing materials and prepared CEOs and senior executives for “make or break” meetings with FDA.
Successfully counseled numerous foreign manufacturers through the process of lifting GMP Warning Letters and Import Alerts (Import Bans).
Negotiated civil and criminal settlements involving government investigations into GMP violations.
Developed responses and strategies to address drug approval issues and FDA complete response letters related to manufacturing and GMP concerns.
Engaged FDA on averting drug shortages due to manufacturing constraints.
Negotiated consent decrees on behalf of manufacturers and individual defendants.
Negotiated many GMP-related consent decrees with FDA, and defend criminal prosecutions of companies and executives under the Park doctrine.
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