LexisNexis Reed Tech

Leverage Our Expertise
in Life Sciences

Who We Serve

LexisNexis Reed Tech serves many of the world’s top pharmaceutical labelers and medical device manufacturers. With customers from small to mid-size producers and distributors of pharmaceutical and medical device products to the very largest global leaders. Our solutions offer the means to increase productivity, comply with regulations and make more informed decisions quickly.

LNRT Icons - Biotech

Medical Devices

Our core business is managing medical device
Unique Device Identification (UDI) product data for global health authorities.

LNRT Icons - Latest Data

34%

of FDA GUDID Electronic Records Submitted Annually

450+

Medical Device unique customers
 since inception

750,000+

Records Submitted to FDA Global UDI Database

Pharmaceutical & Cosmetics

We provide regulatory consulting, outsourced Structured Product Labeling Services (SPL) for US FDA product listings, eCTD, US Agent and other drug listing & establishment registration services.

15+

Years of Structured Product Labeling Experience

1,000+

Pharmaceutical customers including manufacturers

99.95%

Pharma FDA SPL submissions delivered within contracted time

How We Serve

LNRT Icons - Latest Data

34%

of FDA GUDID Electronic Records Submitted Annually

450+

Medical Device unique customers
 since inception

750,000+

Records Submitted to FDA Global UDI Database

15+

Years of Structured Product Labeling Experience

1,000+

Pharmaceutical customers including manufacturers

99.95%

Pharma FDA SPL submissions delivered within contracted time

Webinars and Recordings

UPCOMING
Comply with Pharma Year-End Deadlines: 2024 Mandate Update

Comply with Pharma Year-End Deadlines: 2024 Mandate Update

Wednesday, December 4 | 2 PM ET

Recording
Reed Tech & 1WorldSync – The Role of Medical Device UDI & GDSN in Regulatory Compliance Strategy

Reed Tech & 1WorldSync – The Role of Medical Device UDI & GDSN in Regulatory Compliance Strategy

Recording
Drug Label Research Across the Product Lifecycle

Drug Label Research Across the Product Lifecycle

Knowledge Center

FEATURED - PHARMACEUTICAL
Health Canada Announces Mandatory Use of XML Product Monograph in 2025

Health Canada Announces Mandatory Use of XML Product Monograph in 2025

Health Canada is introducing the mandatory use of the extensible markup language product monograph (XML PM) in phases, with the first phase taking effect on July 18, 2025. This initial phase will require certain submission types to include the XML PM at the time of filing.

PHARMACEUTICAL
Approval of OA REMS Advancement

Approval of OA REMS Advancement

The U.S. Food and Drug Administration (FDA) announced on October 31, 2024, that it has approved a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS).

MEDICAL DEVICE
 Simplify Your Global Regulatory Compliance with a Singular UDI Vendor

Simplify Your Global Regulatory Compliance with a Singular UDI Vendor

As we continue to discuss optimal solutions to support the growth and compliance needs of industry, LexisNexis Reed Tech is committed to providing you with a single UDI vendor and platform.

MEDICAL DEVICE
UDI Regulations from EUDAMED, MDR, FDA, and other Global Health Authorities

UDI Regulations from EUDAMED, MDR, FDA, and other Global Health Authorities

Unique Device Identification (UDI) regulations have been a focus topic for global health authorities. These regulations enhance patient safety, improve supply chain management, and efficient medical device recalls.

What Our Customers Are Saying

Learn about regulations and requirements for global health authorities in the Understanding UDI series.

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CASE STUDY

How Cadwell Implemented a UDI Strategy Customized for a Diagnostic Technology Manufacturer

Cadwell needed to streamline its complex medical device data submission requirement process due to the number of Health and Regulatory Authorities, regions, and divisions involved. In addition, they wanted to gain control over their data which was in disparate sources and spreadsheets.

Affiliations

DEKRA ISO 27001
MedTech Europe
GS1 US Solution Partner
RAPS Premium Solution Partner