LexisNexis Reed Tech
Leverage Our Expertise
in Life Sciences
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.
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
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
Ask the Experts: Reed Tech & 1WorldSync – The Role of Medical Device UDI & GDSN in Regulatory Compliance Strategy
October 15, 2024, 2:00 PM EST
Knowledge Center
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.
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.
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.
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
“Reed Tech customer service is top-notch and very friendly, helpful and professional.”
“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.”
“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.”
The entire Reed Tech team has supported our numerous clients with SPL generation. Never once have they failed us!
Learn about regulations and requirements for global health authorities in the Understanding UDI series.
Affiliations
