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.

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

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

Knowledge Center

FEATURED - PHARMACEUTICAL

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

Pharmaceuticals

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.

Medical Device

Reed Tech Submits First M2M UDI Submission to the AusUDID Pre-Production System

In recent news, Reed Tech became the first company to submit a device record (machine-to-machine) to the AusUDID Pre-Production system successfully.

Medical Device

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

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

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