LexisNexis Reed Tech

Leverage Our Expertise
in Life Sciences

Who We Serve

LexisNexis Reed Tech serves many of the world’s top pharmaceutical labelers and medical device manufacturers. With customers 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 & Cosmetics

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

RECORDING
Ask the Experts: Reed Tech & 1WorldSync – The Role of Medical Device UDI & GDSN in Regulatory Compliance Strategy

Ask the Experts: Reed Tech & 1WorldSync – The Role of Medical Device UDI & GDSN in Regulatory Compliance Strategy

Recording
Drug Label Research Across the Product Lifecycle

Drug Label Research Across the Product Lifecycle

Recording
eCTD v4.0: The Future of Regulatory Submissions

eCTD v4.0: The Future of Regulatory Submissions

Recorded July 30, 2024

Knowledge Center

FEATURED - PHARMACEUTICAL
July 31st Deadline Approaching for CARES Act Report

July 31st Deadline Approaching for CARES Act Report

The FDA CARES Act requires drug manufacturers, repackers and relabelers to submit annual reports on drug production volumes. Here are the key points: Deadline: July 31, 2024, for the 2023 calendar year; Who Must Report: All FDA-registered facilities under section 510(j)(3) of the Federal Food, Drug & Cosmetic Act; What to Report: Annual production volumes for each listed drug.

PHARMACEUTICAL
MoCRA's Impact on Private Label Cosmetic Manufacturers: Navigating the New Era of Beauty Compliance

Market Research in Early-Stage Drug Concept and Discovery

During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market for existing drug products for any number of reasons. These reasons can vary greatly depending on factors such as if the drug is Rx, OTC or biologic or if the drug is an innovator or generic.

MEDICAL DEVICE
Expert Insights on the EU Proposed Legislation EUDAMED Rollout - Approved

Expert Insights on the EU Proposed Legislation EUDAMED Rollout - Approved

As of April 25, 2024, the EC has approved the amendment and the next step will be approval by the European Council and publication in the Official Journal of the EU is anticipated in May.

MEDICAL DEVICE
FDA Plans for Artificial Intelligence and Medical Products

FDA Plans for Artificial Intelligence and Medical Products

AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.

What Our Customers Are Saying

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

Abstract connected dots and lines. Concept of AI technology, Motion of digital data flow. Communication and technology network concept with moving lines and dots. 3D rendering
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