Pharmaceuticals and Biotechnology Regulatory

In a sector defined by regulation, competitive pressure, and payer pushback, we help pharma companies accelerate market entry and sustain competitive advantage.

Subscribe to receive our insights.

In a highly regulated industry like pharmaceuticals and biotechnology, all phases of corporate life require experienced, sophisticated legal analysis and practical, integrated advice. We help you find the opportunities to accelerate product launches and expansion, and shape policy to support innovation.

We draw on broad background and deep experience in highly technical regulatory matters to help get ahead of your problems in a creative and practical way. We engage early to shape regulation, remove unnecessary complexity and anticipate what’s next to drive your business forward.

We know not only the details of the law, but also the nuances – because many of our lawyers have worked in the U.S. Food and Drug Administration (FDA) and others have worked with FDA, EMA, and country regulators for years. Several others have worked in industry, which means we also understand your business, the science behind your business, and your marketplace.

Our services are as varied as the challenges you face. We offer timely, effective counsel on matters that include product development, product testing, approval standards, post-approval compliance, and the science, regulation, and policy driving development of next- generation products. Our lawyers concentrate on specific areas of the law, such as advertising, manufacturing compliance, regulatory exclusivities, over-the-counter (OTC) products, pharmacovigilance, and controlled substances.

Whether you’re bringing new products to market, expanding across borders, or integrating new technologies into your business, the breadth and depth of our global insight enable you to capitalize on change.

Cell, Tissue, and Gene Therapies

Clinical Trials

Combination Products

Compliance and Enforcement

Controlled Substances and Drug Enforcement Administration (DEA)

Drug Safety, Pharmacovigilance and REMS

Hospitals and Health Care Providers

Labelling, Advertising and Promotion

Licensing and Commercial Transactions

Over-The-Counter (OTC) Drugs and Cosmetics

Product Approvals and Dispute Resolution

Product Lifecycle

Psychedelics

Regulatory Exclusivities, Hatch-Waxman and Similar Statutes

Regulatory Inspections and cGMP

Transaction and Securities Disclosure Support and Due Diligence

Vaccines and Immunotherapies

Inflation Reduction Act

From large biotechnology companies to small start-ups, Hogan Lovells will help you stay ahead of the competition in this rapidly evolving field. We provide strategic, practical advice on development, approval, and marketing, ensuring alignment of scientific innovation with regulatory and legal frameworks. Our global team guides clients across jurisdictions, helping secure patent and regulatory protections, including reference product exclusivity under the BPCIA. We advise on biosimilar pathways, demonstrating biosimilarity and interchangeability, and managing complex patent information exchanges. By combining deep scientific understanding with regulatory and IP insight, Hogan Lovells helps clients stay competitive, mitigate risk, and maximize opportunities in the fast-evolving biologics landscape.

Hogan Lovells helps clients navigate the complex regulatory landscape for cell, tissue, and gene therapies, including HCT/Ps and genetically modified products. We advise on FDA compliance, Good Tissue Practice regulations, and equivalent international rules, while supporting marketing strategies that protect regulatory status. Our knowledge spans expedited development pathways (e.g., breakthrough therapy, RMAT), orphan drug and exclusivity considerations, commercialization challenges, and research oversight, including informed consent, participant compensation, HIPAA, and EU privacy compliance. We also monitor global regulatory developments, including EU tissue collection directives and the EU Regulation on Advanced Therapies. As part of this, our Mexican regulatory team provides regulatory advice regarding the adoption of projects involving stem cells, gene therapies, and emerging product types.

Learn more

We guide clients through the full lifecycle of clinical trials for drugs and devices, ensuring regulatory compliance and effective study design. Our team advises on protocol development, ethics committee management, registry submissions, trial contracting, monitoring, inspections, clinical holds, and data read-outs. We support HIPAA, data integrity, cybersecurity, and reimbursement issues, drafting key documents for investigational new drug filings globally, including in the EU, Japan, Australia, and China. We counsel sponsors, CROs, investigators, and IRBs on FDA regulations, EU Clinical Trials Directive, and ICH guidelines. Our biotechnology experience spans vaccines, cell and gene therapies, monoclonal antibodies, xenotransplants, and regulatory considerations for human/animal-derived products and OTC drugs.

Learn more

Combination products – integrating drugs, biologics, and/or devices – are rapidly evolving, with increasingly complex FDA approvals for integrated systems. Hogan Lovells’ Medical Device and Pharmaceuticals and Biotech teams help clients navigate regulatory classification and identify optimal development pathways, minimizing delays and risk. We advise on products combining drugs and biologics or either with devices, whether novel or repurposed, for broad or niche use. Our guidance covers market entry strategies, innovation protection, and overlapping quality and manufacturing requirements across all components. We help clients address these regulatory, commercial, and lifecycle challenges efficiently to accelerate product development and maximize value.

Hogan Lovells helps clients proactively manage FDA compliance and regulatory risk across drugs, devices, and biologics. We advise on inspections, Form FDA 483 responses, Warning Letters, import alerts, recalls, and approval issues, providing real-time, on-site support to identify, remediate, and mitigate compliance risks globally. Our team combines deep knowledge of cGMP, quality systems, and regulatory expectations with strategic advocacy, helping clients prevent or manage enforcement actions, government investigations, civil or criminal proceedings, and derivative litigation. We guide clients in crisis management, process improvements, multi-jurisdictional remediation plans, and negotiations with regulators – ensuring compliance while minimizing business disruption and protecting long-term value.

Our lawyers advise manufacturers, distributors, and researchers on comprehensive controlled substances compliance at the state, federal, and international levels. We guide clients on DEA and state requirements, including registration, scheduling, import/export, suspicious order monitoring, theft/loss reporting, and disposal, as well as products with abuse potential. Our team conducts compliance reviews of SOPs and training, assists with internal process enhancements, and represents clients in investigations or administrative actions. We also counsel pharmaceutical sponsors on scheduling issues for new or existing products. By integrating FDA insight with deep controlled substances knowledge, we help clients navigate complex regulatory frameworks throughout development, marketing, and distribution.

We guide clients across the full spectrum of pharmacovigilance and drug safety, from early development through global post-market obligations. Our team helps navigate FDA requirements – including REMS, post-market safety studies (PMRs), and safety labeling – while addressing operational and legal challenges arising from safety issues. We also draft REMS and PMR submissions, advise on shared REMS and waivers, and deliver sophisticated guidance to help clients mitigate risk, ensure compliance, and safeguard their competitive position.

Changes in government policy, regulation, and the market are transforming hospital operations and health care delivery – constantly adding new challenges to an already demanding environment.

We know how overwhelming it can be trying to effectively navigate today's regulatory environment and capitalize on strategic opportunities. Many members of our team have previously worked in key positions in both the private and public sectors, including the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and the Federal Trade Commission (FTC). We leverage our previous experience as top government officials in regulatory and policy agencies. And we leverage our long record of advising world-class clients in the hospital and health care delivery sector to anticipate future challenges and propose creative solutions.

Learn more

We provide strategic, cross-border guidance on drug and biologic labelling, advertising, and promotion, helping clients achieve commercial objectives while managing legal and regulatory risk. We monitor evolving business practices, enforcement trends, and industry developments across jurisdictions, advising on FDA regulations, First Amendment considerations, FTC guidelines, Anti-Kickback and False Claims Act compliance, and industry codes of conduct. We use a comprehensive set of considerations in our analysis of commercialization and brand strategies, including health care fraud & abuse, Sunshine disclosures, health data privacy, pricing, reimbursement, and product liability. In Europe, we advise on promotional compliance, transparency, SOPs, and engagement with health care organizations, health care professionals and patient organizations.

Our dedicated team of life sciences and health care licensing and commercial transactions lawyers understand the challenges and opportunities that strategic alliances and other partnering relationships present.

Learn more

From design and manufacturing to marketing and promotion, our team advises clients on the full lifecycle of OTC drugs. We guide manufacturers, marketers, and retailers on labeling, Drug Facts compliance, and advertising strategies, including Rx-to-OTC switches and legacy product considerations. Our team addresses regulatory challenges such as Hatch-Waxman exclusivity, adverse event reporting, cGMP standards, compounding, and OTC monograph compliance. With decades of experience – including former FDA attorneys – we help clients navigate the legal and competitive landscape, ensuring compliance while maximizing market opportunities and supporting strategic commercialization of OTC products.

If you need help navigating product approval pathways and standards in the U.S., EU, or Asia, we can assist with the myriad of regulatory protocols – from full NDAs and 505(b)(2) applications to Biologics License Applications (BLAs) and 510 (k)s, as well as accelerated approvals, fast track, priority review, and special protocol assessments. We counsel on variations, combination product issues under the Medical Devices Directive, and regulatory requirements for cell and tissue therapies. When disputes arise, we guide clients through FDA appeal mechanisms, higher-level CDER/CBER engagement, and international regulatory resolution, helping maximize legal benefits while minimizing development and marketing risks.

Our Life Cycle Management team helps clients bring products to market and gain competitive advantage through integrated legal and regulatory strategies. We guide companies from early development through approval and beyond, anticipating FDA expectations and resolving agency challenges. With deep insight in exclusivities, patents, and post-approval planning, our team – including many former FDA lawyers – crafts practical solutions for complex issues. We support every stage: preparing FDA submissions, ensuring GLP compliance, leveraging expedited review programs, securing priority review vouchers, and navigating clinical holds or inspection hurdles. Whether it’s NCE, orphan drug, pediatric, or biologics exclusivity, we help maximize product value and minimize risk.

Hogan Lovells helps clients navigate the rapidly evolving psychedelic therapeutics market, advising on clinical development, FDA approval, and regulatory compliance. Our team guides businesses – from start-ups to established sponsors – through safety requirements, REMS, controlled substances obligations, rescheduling, distribution planning, and product liability management. We support cross-border fundraising, acquisitions, and portfolio expansion, ensuring clients understand the legal and regulatory implications at every stage. By combining deep FDA, neuroscience, and global regulatory insight, Hogan Lovells helps companies capitalize on growth opportunities in this emerging sector while mitigating risk and maintaining compliance in a complex and dynamic legal landscape.

Hogan Lovells advises clients on global patent and exclusivity strategies, including U.S. Hatch-Waxman Act compliance, FDA patent listings, and Form FDA 3542 submissions. We guide clients on patent term extensions, statutory exclusivity, pediatric testing and marketing exclusivity, and orphan drug protections in the U.S. and EU. Our team supports pioneer companies in evaluating potential generic competition, participating in approval processes, and raising timely objections. In Europe, we counsel pioneer companies on the impact of innovator rights of the 2004 EU Pharmaceutical Review Legislation and the effect of recent EMEA guidance documents on comparability of various forms of “biogenerics,” European Court of Justice jurisprudence (the “generics cases”), relevant European Pharmacopoeia monograph activities, and opportunities and threats posed by parallel trade cases such as Bayer Adalat and Kohlpharma.

Hogan Lovells is internationally recognized for FDA regulatory and it’s current Good Manufacturing Practice compliance knowhow, with a team of former FDA officials, lawyers, and regulatory practitioners experienced in complex manufacturing and global supply chains. We advise clients on all aspects of GMP compliance, including internal audits, data integrity investigations, manufacturing obligations, FDA inspections, Form 483 responses, Warning Letters, Import Alerts, enforcement actions, and remediation of GMP deviations or non-conforming products. Our team also manages FDA meetings, drug shortage mitigation, approval issues, consent decree negotiations, and Park doctrine defenses. Combining deep regulatory, technical, and industry knowledge with global reach, we provide practical, business-focused guidance to protect compliance and support operational success.

We serve as special FDA counsel to companies, issuers, and underwriters in conjunction with IPOs and follow-on offerings to perform regulatory due diligence, including a products pathway through the FDA, EMEA or other regulatory bodies, and advise on risk disclosures and opinion letters.

Hogan Lovells has been at the forefront of vaccine and immunotherapy development far before 2020, guiding clients from pre-clinical research through commercialization. We advise on expedited development programs, regulatory exclusivities such as orphan drug status, and commercialization strategies including reimbursement, licensing, and fraud and abuse compliance. Our team also supports global contracting, marketing, and promotion, as well as research oversight, informed consent, participant compensation, HIPAA, and EU GDPR compliance. By combining deep regulatory, legal, and commercial insight, Hogan Lovells helps clients navigate the evolving vaccine landscape, capitalize on emerging opportunities, and bring innovative immunotherapy and vaccine products safely and efficiently to market.

The Inflation Reduction Act (IRA) introduces sweeping changes to Medicare drug pricing, including the Drug Price Negotiation Program, Part D benefit redesign, and inflation rebates for Part B and Part D drugs. These reforms significantly impact how life sciences and health care companies commercialize existing therapies and plan for future products. Our interdisciplinary team – spanning CMS, FDA, and IP experience – guides clients through the IRA’s complexities, helping them adapt strategies from clinical trials to market launch and generic entry. We also support administrative and legislative advocacy as the IRA evolves. Whether you're navigating early-stage development or managing a mature portfolio, we help you align with the new regulatory landscape and seize emerging opportunities.

Hear from our clients and industry leaders

Hogan Lovells’ department is distinguished by its exceptional expertise, responsiveness and commitment to understanding clients’ needs. The team excels at integrating legal strategy with business objectives."

Chambers & Partners, USA Guide, 2025

Hogan Lovells brings clarity and simplified solutions to complex matters during negotiations. The team is highly responsive, and matter experts in the pharmaceutical sector."

Chambers & Partners, Global Guide, 2025

Key contacts

Lynn Mehler

Partner

Lynn Mehler

Partner

Washington, D.C.

Philip Katz

Partner

Philip Katz

Partner

Washington, D.C.

Jane Summerfield

Partner

Jane Summerfield

Partner

London

Hein van den Bos

Partner

Hein van den Bos

Partner

Amsterdam

Ernesto Algaba Reyes

Partner

Ernesto Algaba Reyes

Partner

Mexico City

Meet the Pharmaceuticals and Biotechnology Regulatory team

Representative experience

Instrumental in persuading FDA to change longstanding regulatory position on awarding exclusively to fixed-dose combination products, benefiting Gilead's products in HIV and Hepatitis C fields.

Convinced FDA to give 5-year exclusivity to fixed dose combination products that include a new chemical entity and a previously approved active ingredient.

Successfully sued FDA to overturn denial of orphan drug exclusivity.

Help respond to FDA Form 483 observations, warning letter to close out FDA investigation.

Negotiate settlement of FDA lawsuit alleging cGMP noncompliance.

Conduct internal investigation of promotional practices and help develop and implement enhanced practices.

Audit clinical trial study reports to ensure compliance with adverse event reporting obligations.

Advise on FDA/DEA interplay during drug development and approval process, scheduling under CSA.

Conduct due diligence of FDA and EU regulatory law for IPO.

Advising a research-based pharmaceutical company with respect to a government demand for price reductions under its federal contracts with the U.S. DVA.

Case study: Bringing rare disease innovation to life: Guiding Orphalan’s U.S. market entry.

Orphalan sought to bring its innovative treatment, Cuvrior, to market for patients with Wilson’s disease.

Awards and recognitions

Band 1 for Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia

Chambers & Partners, USA Guide

2020-2025

Band 1 for Life Sciences: Regulatory/Compliance

Chambers & Partners, USA Guide

2023-2025

Band 1 in Life Sciences

Chambers & Partners, Global Guide

2020-2025

Band 1 for Life Sciences & Pharmaceutical Sector (International & Cross-Border) in the UK

Chambers & Partners, Global Guide

2025

Regulatory Firm of the Year

LMG Life Sciences

2024

Resources

Our thinking

Talking the Cure Podcast

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover cutting-edge topics such as AI, digital health, diversity in clinical trials, supply chains, the Inflation Reduction Act, and more.

Learn more

Guide

Life Sciences and Health Care Horizon Guide

Our Horizons edition brings together insights from across our global Life Sciences and Health Care team, exploring the issues and developments shaping the future of the industry.

Learn more