LexisNexis Regulatory Data Management & Transformation Solutions and Services

Data Standards & Transformation ServicesSimplify regulatory data workflows

Expert support for SPL, eCTD, listing, and regulatory data management.

LexisNexis Regulatory Data Management & Transformation Services is a service suite that supports labeling, listing, submission, and regulatory data workflows across SPL, XML, and eCTD processes. It helps manufacturers, distributors, foreign establishments, and labeler companies manage product listing data, create reusable labeling outputs, research approved drug labels, and facilitate communication with the FDA and other Health Authorities.

Submission workflowsReduce submission complexity

LexisNexis Life Sciences supports SPL and XML conversion, eDRL coordination, and eCTD work so teams can manage submission requirements with more clarity. The services support compliant filings, accuracy, and timeliness.

Labeling outputsReuse approved labeling

LexisNexis Life Sciences can turn labeling content from an FDA-accepted SPL Drug Listing file into print- and web-ready materials. That supports package inserts, marketing materials, Med Guides, patient package inserts, and product web pages. (LexisNexis Life Sciences Solutions)

Regulatory supportStrengthen regulatory oversight

LexisNexis Life Sciences helps companies manage product listing data, research approved labels, and navigate changing requirements through consulting, submission data library support, and US Agent support. This supports regulatory planning and communication between foreign establishments and the FDA.

CapabilitiesCore regulatory capabilities

Here’s a practical view of the services in the suite, from submission formatting to ongoing regulatory support.

SPL submission support

Conversion, submission, and eDRL coordination services help teams manage FDA SPL work and related data submission tasks. This includes support for drug and biologic products, as well as drug or device data management. 

SPL content reuse

SPL composition lets teams create print- and web-ready outputs from approved labeling content. It can support package inserts, marketing materials, Med Guides, patient package inserts, and product web pages.

Drug label research

LexisNexis Life Sciences provides access to FDA-approved prescription, OTC, and homeopathic drug products, along with EU centralised prescription drug products. This supports label research and analysis. 

eCTD lifecycle support

LexisNexis Life Sciences facilitates preparation, review, publishing, submission, and lifecycle management for files in the standardized eCTD format. The focus is compliant, accurate, and timely submission support.

Submission data library

SingleSource collects, stores, and can optionally submit global product listing, establishment facility, and labeler company data. It keeps that information in a master submission data library.

Consulting and US Agent

Regulatory consulting helps companies navigate complex and changing requirements. US Agent support serves as the domestic representative for a foreign establishment and facilitates communication with the FDA.

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 Life Sciences Data Standards & Transformation Services for?

If you’re a drug or biologic manufacturer, distributor, foreign establishment, labeler company, or device team handling submission work, this service is built to support that process. LexisNexis Life Sciences provides services for listing, submission, consulting, research, and FDA communication workflows.
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  • Drug manufacturers
  • Biologic manufacturers
  • Distributors
  • Foreign establishments
  • Labeler companies
  • Device teams
Frequently asked questions

They are a suite of services that support labeling, listing, submission, research, and regulatory communication workflows. LexisNexis Life Sciences provides services across SPL, XML, eCTD, product listing data, consulting, and US Agent needs.

LexisNexis Life Sciences supports drug labeling and listing, eDRL coordination, SPL composition, drug label research and analytics, and eCTD file management. It also offers SingleSource data library support, regulatory consulting, and US Agent services.

It provides conversion, submission, and eDRL coordination services to help manufacturers and distributors manage SPL and XML work for drug and biologic products. It also supports drug or device data management and FDA submissions.

It can turn SPL labeling content into print- and web-ready materials. That includes package inserts, marketing materials, Med Guides, patient package inserts, and product web pages.

Yes. LexisNexis Life Sciences facilitates preparation, review, publishing, submission, and lifecycle management for files in the standardized eCTD format.

US Agent support serves as the mandatory domestic representative for a foreign establishment. It facilitates communication between the foreign establishment and the FDA.

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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