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Text Content

 * About Us
   * About Us
   * Our Purpose & Mission
   * Our Team
   * Life Sciences Alliance
   * Reed Tech Corporate
   * Rule of Law
   * Careers
 * Solutions
   * Med Device
     * Unique Device Identification (UDI)
     * Product Data Management
   * Pharma
     * Drug Data Management
     * Drug Label Research & Analytics
     * eCTD Services
     * Health Canada XML PM
     * SPL & XML Services for Rx, OTC, and Biologics
     * US Agent
   * Cosmetics
     * Facility Registration and Product Listing Services (MoCRA)
 * Events
   * Virtual Events
   * News & Events
   * Conferences and Trade Shows
 * Resources
   * Case Study
     * UDI Implementation
     * UDI Submissions
     * UDI Strategy
     * UDI Challenges
     * Pharma Label Proofreading
   * Knowledge Center
     * Medical Device
     * Pharmaceutical
   * Data Sheets
 * Contact Us

 * About Us
   * About Us
   * Our Purpose & Mission
   * Our Team
   * Life Sciences Alliance
   * Reed Tech Corporate
   * Rule of Law
   * Careers
 * Solutions
   * Med Device
     * Unique Device Identification (UDI)
     * Product Data Management
   * Pharma
     * Drug Data Management
     * Drug Label Research & Analytics
     * eCTD Services
     * Health Canada XML PM
     * SPL & XML Services for Rx, OTC, and Biologics
     * US Agent
   * Cosmetics
     * Facility Registration and Product Listing Services (MoCRA)
 * Events
   * Virtual Events
   * News & Events
   * Conferences and Trade Shows
 * Resources
   * Case Study
     * UDI Implementation
     * UDI Submissions
     * UDI Strategy
     * UDI Challenges
     * Pharma Label Proofreading
   * Knowledge Center
     * Medical Device
     * Pharmaceutical
   * Data Sheets
 * Contact Us


LOGIN


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.

LEARN MORE


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.

REQUEST DEMO
LEARN MORE


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.

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LEARN MORE


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

Prev


UPSKILL WITH REED TECH:
ECTD

RECORDED AUGUST 2, 2023

WATCH NOW


UPSKILL WITH REED TECH: YEAR-END DEADLINES

RECORDED ON NOVEMBER 2, 2023

JOIN NOW


ASK THE EXPERTS: CRITICAL STEPS IN IMPLEMENTING YOUR EU MDR/IVDR PLAN

RECORDED: OCTOBER 25, 2023

WATCH NOW


OTC MONOGRAPH UPDATES: WHAT YOU NEED TO KNOW

RECORDED ON OCTOBER 18, 2023

WATCH NOW


ASK THE EXPERTS: WHAT TO KNOW ABOUT BASIC UDI-DI PART II

RECORDED: SEPTEMBER 28, 2023

WATCH NOW


HEALTH CANADA XML PM MANDATE UPDATE

RECORDED AUGUST 24,2023

WATCH NOW


UPSKILL WITH REED TECH:
ECTD

RECORDED AUGUST 2, 2023

WATCH NOW


UPSKILL WITH REED TECH: YEAR-END DEADLINES

RECORDED ON NOVEMBER 2, 2023

JOIN NOW


ASK THE EXPERTS: CRITICAL STEPS IN IMPLEMENTING YOUR EU MDR/IVDR PLAN

RECORDED: OCTOBER 25, 2023

WATCH NOW


OTC MONOGRAPH UPDATES: WHAT YOU NEED TO KNOW

RECORDED ON OCTOBER 18, 2023

WATCH NOW


ASK THE EXPERTS: WHAT TO KNOW ABOUT BASIC UDI-DI PART II

RECORDED: SEPTEMBER 28, 2023

WATCH NOW


HEALTH CANADA XML PM MANDATE UPDATE

RECORDED AUGUST 24,2023

WATCH NOW


UPSKILL WITH REED TECH:
ECTD

RECORDED AUGUST 2, 2023

WATCH NOW
Prev
SEE MORE


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



VIEW POST
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.



VIEW POST
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.



VIEW POST
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)



VIEW POST
SEE MORE


WHAT OUR CUSTOMERS ARE SAYING

“Reed Tech customer service is top-notch and very friendly, helpful and
professional.”

– Regulatory Affairs & Compliance at an international provider of
pharmaceutical, nutritional and veterinary products

“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.”

– Regulatory Director at a premier provider of infection prevention and other
procedural products and services

“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.”

– Operations Head for a global medical device and pharmaceutical maker

The entire Reed Tech team has supported our numerous clients with SPL
generation. Never once have they failed us!

– Operations Manager at Regulatory Professionals Inc.

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LEARN ABOUT REGULATIONS AND REQUIREMENTS FOR GLOBAL HEALTH AUTHORITIES IN THE
UNDERSTANDING UDI SERIES.

Access 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.
VIEW CASE STUDY
SEE OTHER CASE STUDY


AFFILIATIONS


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