Pharmaceutical Regulatory Compliance & Submission Solutions

LexisNexis Life Sciences SolutionsPharmaceutical Solutions
Manage drug product data, labeling, and regulatory submissions with centralized systems and regulatory expertise.
Contact us

LexisNexis Life Sciences Solutions provides an end-to-end, compliance-as-a-service partnership that helps pharmaceutical organizations manage drug product data, labeling, and regulatory submissions. We support the preparation, transformation, and submission of regulatory information required by health authorities.

Submission ManagementStreamline regulatory submissions

Services support the preparation and submission of regulatory files required by health authorities. This helps pharmaceutical organizations manage complex regulatory filing requirements efficiently.

Explore our regulatory submission services

eCTD Publishing

Prepare and publish electronic common technical document (eCTD) submissions for regulatory authorities.

Submission preparation

Prepare regulatory documentation and structured files required for regulatory filings.

Regulatory submission support

Support regulatory teams in managing the submission process and required documentation.

Data CentralizationCentralize product data

Centralized systems help manage drug product listings, establishment registrations, and labeler information. This enables teams to maintain consistent regulatory data across products and organizations.

Explore data management

Drug listing management

Manage regulatory drug listings and related product information required by the FDA.

Establishment registration

Manage establishment registration data required for pharmaceutical regulatory compliance.

Labeler data management

Maintain company and labeler data used for regulatory drug listings and submissions.

Regulatory ExpertiseNavigate regulatory requirements

Regulatory specialists provide guidance and services that help organizations interpret and manage evolving health authority requirements.

Learn about U.S. Agent services
Drug label research & analytics

Regulatory consulting

Provide expert guidance to help organizations understand regulatory submission requirements.

Drug labeling conversion

Convert drug labeling information into FDA Structured Product Labeling (SPL) format.

Drug label data access

Access FDA-approved drug labeling information used for regulatory research and analysis.

Related CapabilitiesExplore supporting pharmaceutical services

These specialized services support key regulatory processes including labeling compliance and regulatory data management.

Pre-built legal workflows library with search and task cards for clause review and due diligence drafting

Structured Product Labeling (SPL)

Prepare and manage FDA Structured Product Labeling submissions, including SPL conversion and drug listing support.

View SPL Services
Custom legal workflow builder showing rule-based automation steps to check for COPPA regulation updates.

Regulatory Data Management

Manage drug product data, establishment registrations, and regulatory information used in regulatory submissions.

View Data Management
Solutions and capabilities

eCTD submission services

Prepare, review, publish, and submit electronic common technical document (eCTD) files for regulatory authorities.

Drug labeling and listing

Convert drug labeling information into FDA Structured Product Labeling (SPL) and support regulatory drug listing submissions.

Regulatory consulting

Provide regulatory expertise to help organizations interpret regulatory requirements.

Drug label data access

Provide access to FDA-approved drug labeling information for regulatory research and analysis.

Product data management

Manage drug product listings, establishment registrations, and labeler information in centralized regulatory systems.

SingleSource™ for Drug Labels

Manage and submit Unique Device Identification (UDI) data to the health authorities to meet regulatory requirements.

Navigator™ for Drug Labels

Search and analyze prescription, OTC, and homeopathic drug label data to quickly find insights, trends, and regulatory information.

U.S. Agent Services

LexisNexis Life Science is your FDA point of contact and supports registration, communications, and inspection scheduling.

Data Security, Privacy, and Governance

Security and privacy you can count on

Privacy by design

LexisNexis protects customer data wherever it is stored, sent, or accessed. We apply privacy by design principles at every stage of development to ensure security and compliance are built in from the start. Our advanced encryption and rigorous compliance protect your sensitive information. 

Strict security protocols

LexisNexis systems meet the highest standards for information security. We partner with trusted, enterprise-grade cloud providers, continuously monitor and improve our infrastructure,
Who are LexisNexis Pharma Regulatory Compliance and Submission services for?

A variety of legal, government, corporate, education, and business organizations who need deep investigations of a people, businesses, or property records. Used when preparing for trial, conducting due diligence and running conflict checks, LexisNexis public records is the right choice in any non-FCRA regulated situation where a complete picture of a person, business or asset is required. Don’t see who you’re looking for? Contact us for a customized demo.

  • Manufacturers
  • Distributors
  • Regulatory Affairs
  • Compliance Teams
What people are saying

Their SPL Services delivers quality results on time, every time. They are committed to meeting the needs of their customers and always keep pace with changes in FDA’s standards. 

 Regulatory AffairsGlobal pharmaceutical company
Frequently asked questions

LexisNexis Life Sciences – Pharmaceuticals is a regulatory data management platform and service suite that helps organizations manage drug product data, labeling, and regulatory submissions.

The services support the preparation and submission of regulatory files including electronic common technical document (eCTD) filings.

Labeling services convert drug label information into FDA Structured Product Labeling (SPL) format and support regulatory drug listing submissions.

Pharmaceutical manufacturers, distributors, and regulatory teams use the solutions to manage drug product data and regulatory submissions.

Organizations can manage drug listings, establishment registrations, labeling information, and regulatory submission files.

Talk to a Life Sciences Regulatory Professional Today

Questions about medical device, pharmaceutical, or cosmetic products or services? We can help.
A LexisNexis regulatory expert will reach out soon.

LexisNexis, a division of RELX Inc., may contact you in your professional capacity with information about our other products, services, and events that we believe may be of interest. You can manage your communication preferences via our Preference Center. You can learn more about how we handle your personal data and your rights by reviewing our Privacy Policy.

Related products

Regulatory submission services

Supports UDI compliance, gap assessments, advisory services, API integration, and global health authority submissions.

Labeling & SPL Services

Provides SPL/XML conversion and submission support for FDA drug labeling, listing, and establishment compliance.

Data Standards & Transformation Services

Manages, validates, and reuses product, establishment, and labeler data for SPL submission workflows

U.S. Agent Services

Provides FDA-required U.S. Agent support for foreign drug and biologic establishments.

Reed Tech is now LexisNexis Life Sciences Solutions

While the Reed Tech name is being retired, the business has long operated as part of LexisNexis. Customers will continue to work with the same regulatory experts, services, and solutions—now unified within LexisNexis Life Sciences to reflect the broader capabilities and global resources of LexisNexis.