Understanding UDI Series

Access the ‘Understanding UDI Series’ for short tutorials and quick reference slides. Learn more about regulations, requirements and timelines for Global Health Authorities.

Global Health Authorities & UDI Submissions
Health authorities around the globe are activating regulations with requirements for medical devices and Unique Device Identification. We are constantly tracking UDI activity. Contact Reed Tech for experienced help with UDI.
Health Canada Submissions
Gain insights into the forthcoming XML Product Monograph regulations and requirements for drug products in Canada.
Risk Evaluation and Mitigation Strategies in Structured Product Labeling Format & Additional Pharma Annual Deadlines

Review the annual deadlines that pharmaceutical companies are required to fulfill to become and remain compliant with the US Food and Drug Administration (FDA), with a special focus on the new REMS in SPL deadline.

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.

Medical Devices

%

~% of FDA GUDID Electronic Records Submitted Annually

Medical Device unique customers since inception

Records Submitted to FDA Global UDI Database

Pharmaceuticals

Years of Structured Product Labeling Experience

Pharmaceutical customers including manufacturers

%

Pharma FDA SPL submissions delivered within contracted time

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

What Our Customers Are Saying
“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

What Our Customers Are Saying
“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

What Our Customers Are Saying
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.

Medical Devices

Achieve UDI Submission for all Global Health Authorities
Build and submit UDI records electronically in Structured Product Labeling (SPL) format or seek subject-matter expertise.
Meet UDI Regulartory Data Submission Timelines
Active channels include US FDA, China NMPA, South Korea MFDS, EU EUDAMED and other emerging regions.
Our Core Business is Managing UDI Product Data
Learn more about varied approaches to managing UDI product data.
Achieve UDI Submission for all Global Health Authorities
Build and submit UDI records electronically in Structured Product Labeling (SPL) format or seek subject-matter expertise.
Meet UDI Regulartory Data Submission Timelines
Active channels include US FDA, China NMPA, South Korea MFDS, EU EUDAMED and other emerging regions.
Our Core Business is Managing UDI Product Data
Learn more about varied approaches to managing UDI product data.

Pharmaceuticals (Rx, OTC, and Biologics)

Simplify Drug Label Research with Quick Access to Targeted Label Information
Navigator™ for Drug Labels helps pharmaceutical regulatory researchers ensure accurate and up-to-date drug label content.
Structured Product Labeling Services for Rx, OTC and Biologics
Manage product listing, establishment facility, and labeler company data across multiple teams with a secure cloud-based solution.
Manage Regulated Drug Product Data in One Central Database
SingleSource™ for Drug Products manages FDA prescription, OTC and animal drug product submissions data in Structured Product Labeling (SPL) format.
Simplify Drug Label Research with Quick Access to Targeted Label Information
Navigator™ for Drug Labels helps pharmaceutical regulatory researchers ensure accurate and up-to-date drug label content.
Structured Product Labeling Services
for Rx, OTC and Biologics
Manage product listing, establishment facility, and labeler company data across multiple teams with a secure cloud-based solution.
Manage Regulated Drug Product Data
in One Central Database
SingleSource™ for Drug Products manages FDA prescription, OTC and animal drug product submissions data in Structured Product Labeling (SPL) format.

Solutions & Services

Med Device Brochure
www.reedtech.com/udi
Pharma Brochure
www.reedtech.com/udi

Learn More About Regulatory Compliance and Product Data Management Solutions

Life Sciences Alliance

Learn More About

Schlafender Hase

www.reedtech.com/udi

Learn More About

Greenlight Guru

www.reedtech.com/spl

Official UDI Provider

Webinars and Recordings

Ask the Experts

What to know about Basic UDI-DI

June 20, 2023 1:00 PM EST

Ask the Experts

What should I know about the EU Legacy Medical Device Amendment?

May 16 2023  1:00 pm EST

Coffee Talk with Reed Tech – EU EUDAMED Testing Update
Recorded March 9, 2023
US FDA Class I UDI-Requirements
Recorded November 3, 2022
Recorded March 3, 2022

Conference and Trade Shows

Featured Event

RAPS Convergence 2023

Regulatory Affairs Professionals Society
Montreal, Canada
October 3 – October 5

Featured Blog Posts

drug sample
Health Canada Now Requiring Second-Language at Post-Authorization Phase
March 20, 2023
drug sample
Simplifying Annual Drug Sample Reporting
February 23, 2023
www.reedtech.com

MoCRA: The Future of Cosmetic Regulations

January 24, 2023
www.reedtech.com

EU Proposal to Extend Legacy Medical Device Transition

January 5, 2023
www.reedtech.com

US FDA Class I Inventory Exception

November 14, 2022
Ultimate Guide to UDI for Medical Devices
August 15, 2022
European Union Flag

DIA Global Labeling Takeaways: Patient Materials and Health Literacy

May 19, 2022
European Union Flag

FDA Drug Distribution Amounts Report: Frequently Asked Questions and More

April 14, 2022

Life Sciences Products

Medical Devices

Pharmaceuticals

Life Sciences In The News