Leverage Our Expertise in Life Sciences
LexisNexis Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.
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
55,000+ Pharma FDA SPL submissions
Medical Devices
Achieve UDI Submission with US FDA and Other Global Health Authorities
Build and submit UDI records electronically in Structured Product Labeling (SPL) format or seek subject-matter expertise.
Manage Medical Device Product Data for UDI & Syndication
Serving the medical device manufacturing industry in the areas of compliance, data management and regulatory requirements experience.
Gain Quick Insights Into Quality Safety and Regulatory Data
Navigator ™ for Medical Devices serves device manufacturers, law firms, consultants, investors, hospitals, insurers and more.
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.
Downloadable Resources
Med Device Brochure
Pharma Brochure
Learn More About Regulatory Compliance and Product Data Management Solutions
More Resources
What to Know for Medical Device UDI Compliance in South Korea
South Korea Ministry of Food and Drug Safety (MFDS) began UDI activity in 2018 with the MFDS notification No. 2020-29.
Health Canada is adopting a structured product monograph format for the preparation, submission and approval of human prescription drugs marketed, sold or distributed in Canada.
To market medical devices in China, the regulatory process to comply with NMPA UDI may be unfamiliar, requiring experienced help.
To bring a medical device to market in the European Union, there are a number of complex regulatory-related tasks that will need attention.
Knowledge Center
Virtual Events & Recordings
Recorded June-August, 2021
Recorded July 20, 2021
Recorded August 19, 2021
Recorded May 20, 2021
Featured Blog Posts
August 21, 2021
August 11, 2021
New Drug Application (NDA): Back to the Basics
July, 2021
June 26, 2021
June 24, 2021
Life Sciences Products
Medical Devices
Pharmaceuticals