Regulatory Compliance Solutions

Track changing obligations, manage regulated product data, and support confident compliance decisions with LexisNexis regulatory compliance solutions.

Life sciences regulatory compliance

Manage regulated product data, labeling, listings, UDI submissions, and health authority requirements for pharmaceutical, medical device, biologic, OTC, veterinary, and cosmetics portfolios.

SPL & XML Services for Rx, OTC & Biologics

Structured Product Labeling services that help drug and biologic manufacturers compose, convert, validate, and submit SPL and XML content for FDA drug listing, establishment registration, eDRL, eCTD, Health Canada XML Product Monograph, and related regulatory requirements.

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SingleSource for Drug Products

A secure, validated cloud-based platform for managing FDA prescription, OTC, veterinary, and animal drug product submission data in SPL format, with guided workflows for labeling, listing, labeler code, establishment registration, and company data management.

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Navigator for Drug Labels

Drug label research and analytics that help pharmaceutical regulatory teams search, compare, monitor, and analyze U.S. and centralized EU human drug label information to support label development, competitive research, and change monitoring.

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U.S. Agent Services

FDA U.S. Agent services for foreign drug, biologic, and device establishments that need a U.S.-based regulatory contact for establishment registration, FDA communications, inspection coordination, and related compliance support.

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MedTech Compliance

Regulatory compliance services for medical device teams that need support with UDI strategy, compliance remediation, global health authority requirements, training, gap assessments, API integration, data analytics, and advisory support.

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SingleSource Medical Devices: Centralized UDI Data Management

Streamline global UDI data management and submissions across the product lifecycle with one centralized compliance solution. Collect, validate, transform, submit, and maintain data for FDA GUDID, EU EUDAMED, China NMPA, South Korea MFDS, Australia AusUDID, and evolving requirements—while supporting traceability, version control, audit readiness, and cross-functional collaboration.

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Legal obligations and regulatory change management

Move from awareness to action with tools that help teams identify applicable obligations, monitor changes, maintain registers, and align compliance work to business requirements.

LexisNexis® Regulatory Compliance

Legal obligations register and alerting solution that combines regulatory content, alerts, business-language guidance, and compliance registers to help GRC teams understand obligations and turn legal change into action.

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Legislative and regulatory tracking

Monitor proposed bills, regulations, agency activity, calendars, and policy developments so government affairs, legal, and compliance stakeholders can respond before change becomes operational pressure.

State Net®

Legislative and regulatory tracking tool with advanced search and customizable reports to simplify managing legal information.

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SEC and corporate compliance intelligence

Research disclosure trends, benchmark filings, analyze SEC materials, and monitor public-company compliance developments with specialized corporate and securities intelligence.

Protégé powered

Intelligize+ AI™

SEC compliance intelligence platform for disclosure research, peer benchmarking, accounting standards, SEC comment letters, regulatory materials, AI analysis and grounded first drafts.

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Compliance guidance and policy support

Give legal and compliance teams practical guidance for interpreting requirements, comparing laws, preparing policies, and coordinating response across practice areas.

Practical Guidance®

Legal resource that helps you quickly find relevant cases, laws, and expert insights, all directly linked to the guidance you’re using for your legal work.

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Lexis+® Corporate Compliance Suite

A workflow suite of compliance products designed to help teams identify emerging risks, alert in-house counsel, brief the scope of regulatory change, and assist with drafting revised policies.

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Frequently asked questions

Regulatory compliance solutions are software, content, data, analytics, news, and expert services that help organizations understand obligations, monitor legal and regulatory change, manage regulated data, assess risk, and document compliance workflows.

LexisNexis can help organizations monitor regulatory change, manage legal obligations, track legislation and regulations, support life sciences submissions, research SEC and corporate compliance requirements, develop policy response, and connect related risk, news, and data workflows.

LexisNexis solutions help teams monitor bills, regulations, agency activity, filings, legal developments, and changing obligations. Teams can use these insights to assess impact, maintain compliance registers, alert stakeholders, and coordinate response across the organization.

The right solution depends on the workflow. Use LexisNexis Regulatory Compliance for legal obligations management, State Net for legislative and regulatory tracking, life sciences solutions for SPL, UDI, MoCRA, and health authority submissions, Intelligize for SEC and disclosure intelligence, and Practical Guidance or Lexis+ Corporate Compliance Suite for policy and legal workflow support.

LexisNexis supports pharmaceutical, medical device, biologic, OTC, veterinary, and cosmetics compliance workflows, including Structured Product Labeling, drug listing, UDI data management, health authority submissions, U.S. Agent services, regulatory data standards transformation, and MoCRA facility registration and product listing.

Yes. Related LexisNexis solutions can support enhanced due diligence, regulatory news monitoring, adverse media review, API-driven data delivery, and internal compliance data integration. These workflows may involve Nexis Diligence+, MLex, Law360, Nexis Data+, or LexisNexis AI solutions depending on the use case.

Pricing depends on the products selected, number of users, workflow complexity, content and data needs, integration requirements, and geographic or regulatory scope. Contact LexisNexis to discuss the best solution mix and pricing for your organization.

Related solutions

The following solutions can support compliance programs, but they should be positioned as related tools rather than the core ownership of this page. This keeps the page from competing directly with existing News, Risk Management, Business Analytics, Business Operations, and AI solution pages.

MLex®

Specialized news service covering global regulatory developments, delivering breaking news and analysis on major matters like antitrust, data privacy, financial crime, and M&A worldwide.

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Law360®

Legal news subscription with 200+ daily articles covering major litigation, legislation, regulations & corporate deals across 60+ practice areas.

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Nexis Diligence+™

Due diligence software that helps companies mitigate reputational, regulatory, financial and strategic risks when overseeing an M&A or screening a business.

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Nexis® Data+ Regulatory Compliance

API platform with structured regulatory, legal, and news data to support compliance monitoring, risk assessment, and integration into regulatory compliance systems.

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Protégé powered

CounselLink+™

Corporate legal operations platform that offers reports, analytics, and dashboards to help legal teams make data-driven decisions.

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Protégé powered

LexisNexis AI Solutions

Protégé-powered AI solutions may support compliance research, drafting, summarization, and analysis when teams need trusted AI capabilities inside legal, business, and regulatory workflows.

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