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Our Purpose & Mission Our Team Life Sciences Alliance Reed Tech Corporate Rule of Law Careers Solutions Med Device MedTech Compliance Solution Unique Device Identification (UDI) Product Data Management Pharma Pharma Professional Services SPL & XML Services for Rx, OTC, and Biologics Drug Data Management Drug Label Research & Analytics eCTD Services Health Canada XML PM US Agent Cosmetics Facility Registration and Product Listing Services (MoCRA) Events Virtual Events News & Events Conferences and Trade Shows Resources Case Study UDI Implementation UDI Submissions UDI Strategy UDI Challenges Pharma Label Proofreading Knowledge Center Medical Device Pharma and Cosmetics Data Sheets Contact Us LOGIN Medical Device SingleSource™ for Medical Devices SingleSource™ for Medical Devices GDSN US FDA UDI Submissions Pharmaceutical SingleSource™ for Drug Products Navigator™ for Drug Labels Other Pages Intellectual Property Government Solutions Corporate 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. LEARN MORE 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. REQUEST DEMO LEARN MORE 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. REQUEST DEMO LEARN MORE 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 Part II: Insights to MDR/IVDR QMS, Nonconformities and Special Scenarios Recorded on April 25, 2024 WATCH NOW Ask the Experts: Comply with the China Class II Medical Device UDI Deadline in June! Recorded on April 23, 2024 WATCH NOW Ask the Experts: Insights to Transition Timelines for Placing Legacy MD/IVD Products on the EU Market Recorded on March 07, 2024 WATCH NOW How to Handle Missed Year-End Deadlines Recorded on February 21, 2024 WATCH NOW Upskill with Reed Tech: Year-End Deadlines Recorded on November 2, 2023 WATCH NOW SEE MORE Knowledge Center FEATURED - PHARMACEUTICAL MoCRA’s Impact on Private Label Cosmetic Manufacturers: Navigating the New Era of Beauty Compliance The Modernization of Cosmetics Regulation Act (MoCRA) is here, and it’s about to shake up the industry. As the FDA gears up to implement MoCRA by July 2024, it’s time for private label manufacturers to get their ducks in a row and embrace the new era of beauty compliance. VIEW POST Pharmaceuticals 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. VIEW POST Medical Device Reed Tech Submits First M2M UDI Submission to the AusUDID Pre-Production System In recent news, Reed Tech became the first company to submit a device record (machine-to-machine) to the AusUDID Pre-Production system successfully. VIEW POST Medical Device 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) VIEW POST SEE MORE What Our Customers Are Saying Reed Tech customer service is top-notch and very friendly, helpful and professional.” – Regulatory Affairs & Compliance at an international provider of pharmaceutical, nutritional and veterinary products 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.” – Regulatory Director at a premier provider of infection prevention and other procedural products and services 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.” – Operations Head for a global medical device and pharmaceutical maker The entire Reed Tech team has supported our numerous clients with SPL generation. Never once have they failed us! – Operations Manager at Regulatory Professionals Inc. Learn about regulations and requirements for global health authorities in the Understanding UDI series. Access Series 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. VIEW CASE STUDY SEE OTHER CASE STUDY Affiliations Follow Follow Follow Contact Us Copyright 2024 LexisNexis Privacy Policy | Privacy Center | Cookie Policy | Ad Choices | Terms and...