Saul Ewing's Regulatory & Compliance Practice helps clients navigate complex regulatory frameworks across federal, state, and local jurisdictions. We represent businesses of various types and sizes across a range of highly regulated industries, including food, beverage, agribusiness, cannabis, energy, environmental, health care, insurance, and public utilities.
For these organizations, we provide day-to-day regulatory counseling grounded in a practical understanding of how businesses operate, delivering compliance strategies that align with operational realities. Our advice goes far beyond the text of a regulation. We analyze how rules have been interpreted and enforced, how they are likely to evolve, and what regulators expect in practice.
Another aspect of our practice includes supporting our clients' broader business objectives, whether structuring a merger, negotiating a commercial agreement, launching a new product, or building a business from the ground up. We provide multi-state compliance assessments, conduct regulatory due diligence, assess antitrust risk, and design tailored compliance frameworks. In addition, we represent clients facing government investigations and enforcement actions before a wide range of state and federal agencies, advising on strategy, response, and resolution.
Our team includes former regulators with the Food & Drug Administration (FDA), Internal Revenue Service (IRS), and state environmental departments, as well as veterans of state and local government, lobbyists, and attorneys who have participated in drafting regulations now in force. This firsthand regulatory experience informs our counsel, enabling us to anticipate agency priorities, deliver clear, defensible risk assessments, and guide effective responses to regulators.
Our core areas of focus include:
Cannabis
Our Cannabis team guides both marijuana and hemp clients through the process of state agency licensure, including entity structuring, preparation of comprehensive license applications, and capital structuring compliance. We also advise on post-licensing compliance, including standard operating procedures, employee training, seed-to-sale tracking, product labeling and testing requirements, and advertising restrictions. In addition, we counsel on FDA and state agency compliance for food, beverage, and dietary supplement manufacturers and develop state law surveys in a variety of issue areas.
Cybersecurity & Privacy
On behalf of clients in various industries, our Cybersecurity & Privacy team performs regulatory compliance mapping, helps build defensible security programs, conducts tabletop exercises, and develops cyber risk reporting frameworks. In the event of a cybersecurity incident, we assist clients with reporting to regulators and data protection authorities, and we defend government investigations and proceedings. We also guide clients on developing processes and policies to meet the requirements stipulated by a variety of data privacy laws, such as the Health Insurance Portability and Accountability Act (HIPAA), the General Data Protection Regulation (GDPR), the Family Education Rights and Privacy Act (FERPA), and the Gramm-Leach-Bliley Act (GLBA).
Energy
We advise a wide variety of participants in the energy industry on the development and operation of energy projects. Our practice includes counseling on air, water, and solid waste permits required by environmental authorities, environmental impact reviews, zoning and land use approvals, transmission line siting, pipeline permits, interconnection approvals, renewable energy and clean technology programs, and regulatory approvals for transactions and infrastructure development. Our team has considerable experience helping clients navigate community opposition, land use restrictions and interconnection challenges, and on behalf of one client, worked for years to get new legislation facilitating solar development adopted. We also represent clients in government investigations and defend civil, criminal or administrative enforcement actions and ensuing litigation.
Environmental
Our Environmental attorneys advise clients on matters under federal environmental and state statutes, including the National Environmental Policy Act (NEPA), Clean Air Act, Clean Water Act, Solid Waste Disposal Act, the Resource Conservation and Recovery Act (RCRA), the Comprehensive Environmental Response Compensation and Liability Act (CERCLA / Superfund), and the Natural Gas Act. We provide strategic roadmaps on compliance procedures, permitting processes and anticipated litigation. We also counsel on self-disclosure reporting obligations and how to respond to notices of permit noncompliance. We regularly interact with state and federal agencies such as the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and Department of Justice (DOJ), and their individual bureaus, appeals boards, and state attorneys general. We also defend enforcement proceedings under CERCLA, RCRA, and other environmental statutes.
Food, Beverage & Agribusiness
Attorneys in our Food, Beverage & Agribusiness practice counsel clients on the regulatory requirements of the FDA and U.S. Department of Agriculture (USDA), including compliance with the Food Safety Modernization Act (FSMA). We also advise on state and local laws and regulations related to animal health, product development, claim substantiation, labeling, promotion, distribution, transportation, registration, reporting, recalls, employment-based visas and other employment requirements, international exports, pesticide and biotechnology regulation, and participation in state and federal agricultural programs. In addition, our attorneys handle environmental project permitting, defend enforcement actions, provide guidance on government investigations, and conduct regulatory due diligence and post-closing compliance integration when our clients are involved in a merger or acquisition.
Health Care
In our Health Care practice, we advise on compliance with HIPAA and state privacy laws as well as federal and state fraud and abuse, anti-kickback, and physician self-referral statutes and regulations. We also counsel on licensing, accreditation and survey-related matters, government investigations, and Affordable Care Act compliance. Through Certificate of Need applications, our attorneys have assisted academic medical centers, hospitals, long-term care facilities, ambulatory surgical centers, and other facilities in obtaining state approval for new facilities, expansions, and changes of ownership.
Insurance
Our Insurance team advises carriers on complying with state insurance department requirements, including multi-state compliance with rate increase filings, advertising review, market conduct compliance, and cancellation or nonrenewal rules. We secure approvals for new product lines, provide advice on capital deployment and management, and conduct underwriting risk analyses. We also advise on enterprise risk reporting obligations, reinsurance registration, carrier and producer licensing, fronting arrangements, and MGA / MGU structuring. In addition, we counsel on mergers and other corporate transactions and provide strategic regulatory guidance aligned with our clients' business objectives.
Public Utilities
Our Public Utilities attorneys represent gas, electric, water, and wastewater utilities in Delaware, Maryland, New Jersey, and Pennsylvania. We handle rate proceedings, administrative enforcement actions, and other regulatory proceedings before state public utility commissions, including appeals. Our work includes filing comments on proposed regulations, advising on certificates of public convenience and necessity, licenses, and permits, and conducting financial audits. In addition, we procure state regulatory commission approval for mergers, acquisitions, and asset sales on behalf of public utilities and private equity funds.
