Government and Regulatory Affairs

Banking Compliance / Consumer Products & Retail / Corporate Group / Government and Regulatory Affairs / Insurance Services / Intellectual Property / Labour and Employment / Real Estate and Construction

We understand that, to a large extent, the success of any organization hinges on its adherence to different sets of regulatory frameworks.

Our professionals passionately represent clients in legislative, regulatory, and administrative matters bringing an exceptional sense of commitment and depth of experience to their work.

Some of the hallmarks of our service include a multifaceted blend of knowledge about relevant industries and government processes, strong relationships with decision-makers, and a knack for devising innovative solutions.

From local issues to matters of national and international import, Longship International is your trusted partner in achieving success.

Consortia Management

Our multidisciplinary team of attorneys, policy analysts, compliance specialists, and project managers stand ready to provide support, help you define strategic goals, and generate meaningful deliverables.

We facilitate strong and constructive international dialogues among suppliers, regulators, and other stakeholders, contributing to advance cross-sector collaboration between healthcare professionals, and patient groups, including efforts related to patient-centered drug development, clinical research, patient advocacy, and sustainable sourcing.

Government Contracts

Longship International’s government contracts team provides the strategic counsel you need to acquire, negotiate and execute contracts with public entities.

With our expert guidance, your organization will be able to seize business and procurement opportunities, as well as acquisitions and other transactions.

We also represent clients in bid protests, claims, qui tam and False Claims Act cases, and other complex litigation and discovery proceedings before federal district and appellate courts, the U.S. Court of Federal Claims, the Boards of Contract Appeals, the Government Accountability Office and various federal administrative tribunals.

Customs and International Trade

Whether it’s a multinational corporation or a small business looking to expand abroad, we provide expert regulatory, policy, and compliance counsel to help organizations of all sizes pursue opportunities in the global marketplace.

We are committed to helping you attain international success with seamless cross-border transactions and detailed subject-matter expertise in matters such as:

Import compliance
Export controls and OFAC sanctions
Trade remedies
Trade policy
CFIUS and national security

FDA-Regulated Products

Longship International puts at your disposal dedicated practices focusing on each segment of the Food and Drug Administration (FDA) and the Federal Food, Drug and Cosmetic Act (FDCA).

We partner with stakeholders in the food, pharmaceutical, health, and life sciences sectors, as well as other impacted industries, to navigate FDA regulations and agency interactions.

From product concept to creation, we work side by side with you to understand your business and provide tailored advice. Throughout the entire process, you can count on us to deliver highly personalized counsel laser-focused on your goals.

Drugs and Medical Devices: When it comes to pharmaceutical innovation, your success is proportional to your ability to comply with a complex framework of regulations related to clinical development, marketing authorization, commercialization strategies, and post-marketing compliance.

We perform facility audits and advise on clinical trial contracting, internal compliance audits, due diligence reviews, expanded access, labeling, advertising, promotion, recalls, competitor issues, investigations, enforcement, and related matters.

Bioscience Consulting

With a team that includes lobbyists and public policy professionals, we help advance the mission of stakeholders in the health and life sciences industry, including:

Hospitals
Clinics
Academic medical centers
Medical device and life science companies
Patient advocacy groups
Membership trade associations
Health professional societies
Among others

Our expert guidance and our ability to build bridges with agencies such as the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA) allow our clients to shape legislative, executive branch and regulatory activity at the highest level.

Lobbying and Public Policy

Our team’s extensive experience impacting policy decisions speaks for itself and enables us to deliver creative solutions to complex government challenges.

Thanks to our deep policy knowledge, an approach that privileges results, and strong working relationships with government officials we are uniquely positioned to build coalitions that support your goals.

Regardless of the scope and size of your organization, you can trust us to deploy across the country to meet your government relations goals at any time.

Privacy and Cybersecurity

We help organizations make sense of the laws and guidelines that apply to their data processing and assist them in creating policies and procedures designed to achieve and maintain compliance.

Should a cybersecurity incident threaten your business or your reputation, we are here to help. We stand ready to provide assistance in class-action lawsuits, data breach response, and regulator inquiries.

Our international, multidisciplinary team has expensive experience helping clients navigate frameworks and legislation such as:

California Consumer Privacy Act (CCPA)
General Data Protection Regulation (GDPR)
Health Insurance Portability and Accountability Act (HIPAA)
Institutional Review Board (IRB) Common Rule
Gramm-Leach-Bliley Act (GLBA)
National Association of Insurance Commissioners (NAIC) model laws
Fair Credit Reporting Act (FCRA)
Federal Trade Commission (FTC) Act
Payment Card Industry Data Security Standards (PCI DSS)
International Organization for Standardization (ISO) 27001-2
National Institute of Standards and Technology Cybersecurity Framework (NIST CSF)

Public-Private Partnerships (PPP)

Our results-oriented team is prepared to handle all stages of P3 projects, from client-focused strategy formation and financing to risk management and procurement to negotiations and transactions.

Our P3 work across the U.S. has seen us assisting local governments, healthcare organizations, public safety agencies, authorities, school districts, utilities, and other public-sector entities. In all cases, we pride ourselves on delivering practical, forward-thinking solutions that achieve meaningful results.

With extensive experience serving clients in both the public and private sectors and multiple former local senior government officials in our team, we bring a unique perspective that allows us to swiftly uncover both untapped opportunities and potential pitfalls.

Telecommunications

We understand the federal and state laws and regulations that affect the communications ecosystem.

With a strong combination of regulatory, transactional, litigation, dispute resolution, fand enforcement experience in the communications field, we deliver practical and grounded counsel on high-impact areas, including a wide range of Federal Communications Commission (FCC) regulations and policies, such as:

Spectrum policy
Licensing and use
5G and other communications infrastructure
Broadband regulation
Telehealth
Interconnection
Telephone Consumer Protection Act (TCPA)
Privacy and data security
Universal Service Administrative Company (USAC) application processes
Audits and appeals

When direct interaction with government agencies becomes necessary in order to shape policy or achieve other results, we are ready to advocate on your behalf before institutions such as the FCC, the National Telecommunications and Information Administration (NTIA), the U.S. Department of Justice (DOJ), the Department of State and the Federal Trade Commission (FTC).