LexisNexis Reed Tech
Leverage Our Expertise
in Life Sciences
Who We Serve
LexisNexis Reed Tech serves many of the worldโs 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.
Medical Devices
Our core business is managing medical device
Unique Device Identification (UDI) product data for global health authorities.
34%
of FDA GUDID Electronic Records Submitted Annually
450+
Medical Device unique customersโจ 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
34%
of FDA GUDID Electronic Records Submitted Annually
450+
Medical Device unique customersโจ 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
Knowledge Center
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.
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).
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.
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.
Affiliations
