April 22, 2025

Electronic Common Technical Document (eCTD) Services

The Electronic Common Technical Document, commonly referred to as eCTD, is a standard format for submitting regulatory applications, amendments, supplements and reports to Global Health Authorities. eCTD is structured into five modules of information and data relating to a medicinal product and allows for electronic submission from applicant to regulator using an XML backbone as a navigation file and for effective version...

April 10, 2025

EUDAMED Compliance: A Practical Guide for 2025

With the UDI/Device Registration module in the EU’s EUDAMED database expected to begin mandatory product reporting in January 2026, the window to prepare is rapidly closing. Is your organization ready to meet the new UDI and regulatory data submission standards? Download our free whitepaper to get a step-by-step roadmap to compliance — designed specifically for medical device manufacturers , regulatory...

November 22, 2024

Modernization of Cosmetics Regulation Act (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic regulations, requires the Food and Drug Administration (FDA) to create Good Manufacturing Practices for all cosmetics manufacturers. The law states that these established practices must include mandatory reporting of serious adverse health events caused...

September 14, 2024

Product Data Availability for GS1 Compliance

What does it mean to ‘share’ medical device product data with ‘downstream stakeholders’? This is a question we often receive. The answer weaves a path from medical device product data, through the regulatory requirements, with a stop at commercial requirements and ultimately to the end receiver with a specific use case.

July 18, 2024

Global UDI Summary of Health Authorities

Update on Global Health Authorities (EUDAMED, AUSTRALIA AusUDID and others)

June 19, 2024

MedTech Compliance Solutions and Service

Often, regulatory enforcement actions are due to a breakdown in compliance systems, where the right resources are limited or a quality culture reinforcement is needed. MedTech Regulatory Compliance from Reed Tech is here to help.

April 11, 2024

UDI Data Solutions for Medical Devices

SingleSource™ for Medical Devices is a product data management system for submission of Unique Device Identification (UDI) data to global health authorities. Centralizing UDI product data helps achieve regulatory compliance, creates a shared view for in-country legal representation and stages data for potential commercial trading partners.

April 04, 2024

Pharma Suite of Services

The pharmaceutical industry is built upon life-changing innovation. Global Health Authorities, such as the US FDA and Health Canada, create strict guidelines and mandates to ensure the safety and efficacy of drugs born of these innovations. Here at LexisNexis Reed Tech, we understand the complexities of navigating this landscape. To help our customers succeed, we have created a comprehensive suite of pharmaceutical regulatory...

March 30, 2024

UDI for the C-Suite

UDI touches many areas of a medical device organization, from regulatory, labeling and manufacturing to quality assurance—and even core business departments such as finance and legal. For these reasons, UDI compliance is a project that senior leadership needs to support.

March 27, 2024

Cosmetics Suite of Services

The cosmetics industry continues to expand and evolve. With this, FDA, among other Global Regulators, is committed to implementing new guidelines and mandates to ensure the safety and well-being of consumers.

July 23, 2023

SPL-Driven Composition Process

Improve your publishing process for promotional materials—including package inserts—by migrating your FDA-approved drug label content directly into print- and web-ready files.

July 14, 2023

SPL and eDRL Solutions and Services

Operating in a highly regulated industry with mandated deadlines requires fast turnaround time and a high degree of accuracy. Few tasks are more time consuming and tedious than gathering, converting and submitting SPL data to the FDA.

September 13, 2022

SingleSource for Drug Products

SingleSource™ for Drug Products was designed with the customer experience in mind. To help users save time and be more productive, we have incorporated clean, intuitive forms and automatic defaults in a smarter system that anticipates your needs. Our thorough data ingestion process ensures that you are never starting from scratch. Throughout our forms, consistency is key allowing for a smooth, easily navigated process...

July 15, 2022

South Korea – Intro to UDI

Browse UDI Regulation in South Korea

June 12, 2022

UDI: A Guide to Device Identifiers

Many questions arise about medical device DIs (Device Identifiers), as industry members work through implementing UDI within their organizations. This guide will teach you the basics about this essential aspect of Unique Device Identification (UDI). Download this eBook to learn: The anatomy of a UDI How to obtain, assign and manage DIs Considerations when choosing an issuing agency When a new DI is needed...

May 27, 2022

Navigator for Drug Labels

Researching and monitoring the many regulatory changes and the competitive landscape for your drug labels is both complex and time consuming. Expedite and simplify your research and maintain a competitive edge with Reed Tech Navigator for Drug Labels. Navigator is an advanced digital research tool that combines over 290,000 current drug labels and all historical FDA-approved branded and generic prescription drugs, OTC...

February 25, 2022

Medical Device Terminology

Decode the acronyms behind global medical device compliance From UDI and GUDID to EUDAMED and GS1 standards, medical device regulatory terminology spans a growing list of acronyms and agency-specific definitions. This glossary breaks down the terms compliance and regulatory affairs teams encounter most — covering FDA, EU MDR/IVDR, GS1, and HIBCC terminology in one reference. Download PDF

December 05, 2020

National Drug Code Assignment Guide

All drug products on the market in the U.S. require an NDC. But how do you get one? How do you obtain an NDC Labeler Code? How many digits should your NDC be? What does each code segment mean? Download this e-book to learn: How NDCs are structured The difference between NDC Labeler, Product and Package Codes Strategies for managing NDCs for your drug product portfolio Next steps to get started Downl...

October 04, 2020

Ultimate Guide to UDI For Medical Devices

The Reed Tech UDI system is a proven solution that assists medical device manufacturers in complying with the FDA’s mandate to submit product information to the Global Unique Device Identification Database (GUDID).

March 27, 2020

China NMPA – Intro to UDI

Browse UDI Regulation in China

March 20, 2020

SingleSource™ for Medical Devices

Simplifying and refining complex compliance and monitoring activities allows professionals in Regulatory Affairs and Quality Assurance roles to focus on the bigger picture. Being aware of new mandates and how your organization will be impacted is just the start.