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.
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
We provide outsourced Structure Product Labeling Services (SPL) for US FDA product listings. Additionally, manage regulated drug product data in one central database.
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
Knowledge Center
FDA Releases MoCRA Draft Guidance
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.
FDA has Updated eCTD Guidance to Recommend Structure-Data Files
In November of 2022, the Food and Drug Administration (FDA) published a new version of the eCTD TECHNICAL CONFORMANCE GUIDE, amending it to include a new section. This new section, 3.3.3, focuses exclusively on structure-data files.
Understanding FDA Exemptions to UDI Requirements
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance patient safety, improve post-market surveillance, and facilitate the identification of medical devices.
Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID
The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID)
Learn about regulations and requirements for global health authorities in the Understanding UDI series.
Affiliations
