Leverage Our Expertise
in Life Sciences
LexisNexis Reed Tech enables innovators to accomplish more by helping them understand the nuances of regulatory requirements, create product data management strategies, and meet compliance deadlines on time.
Our customers create life-changing innovations, we help solve their complex regulatory challenges.
Who We Serve
Reed Tech serves many of the world’s top pharmaceutical labelers and medical device manufacturers. Our customers range 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 customers since inception
750,000+
Records Submitted to FDA Global UDI Database
Pharmaceutical
We provide 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 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
Ask the Experts: Critical Steps in Implementing Your EU MDR/IVDR Plan
Recorded: October 25, 2023
Knowledge Center
MoCRA Submission Encouraged by Dec. 29, 2023; Enforcement Delayed
On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the MoCRA by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline. However, it will delay enforcement for a period of six months until July 1, 2024
FDA has Updated eCTD Guidance to Recommend Structure-Data Files
In November of 2022, the Food and Drug Administration (FDA) published a new version of the eCTD TECHNICAL CONFORMANCE GUIDE, amending it to include a new section. This new section, 3.3.3, focuses exclusively on structure-data files.
Understanding FDA Exemptions to UDI Requirements
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance patient safety, improve post-market surveillance, and facilitate the identification of medical devices.
Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID
The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID)
What Our Customers Are Saying
“Reed Tech customer service is top-notch and very friendly, helpful and professional.”
“Excellent customer and technical support. Reed Tech is a true partner – an extension of our internal resources. Their software solutions are enabling us to successfully meet UDI compliance dates in the US and UK.”
“Reed Tech has experts in Drug Listing and UDI and we can always count on them for their guidance for the best approach to be taken when needed.”
The entire Reed Tech team has supported our numerous clients with SPL generation. Never once have they failed us!
Learn about regulations and requirements for global health authorities in the Understanding UDI series.
Affiliations
