Do your products have FDA Obsolete Codes? There are significant changes with FDA GMDN compliance, and we’re here to help you navigate them. Join our free webinar to learn what’s changing & why it matters, get step-by-step guidance to update your records, and discover how LexisNexis Reed Tech can make compliance easy! Not sure where to start? We’ve got you covered! https://hubs.ly/Q038GnGc0
LexisNexis Reed Tech
IT 服务与咨询
Horsham，Pennsylvania 1,726 位关注者
Regulatory compliance and product data management solutions for medical device manufacturers and pharmaceutical labelers
关于我们
Healthcare relies on regulatory product data submissions for quality, safety, reliability and transparency, benefitting the entire supply chain. Reed Tech is proud to play a role as both a regulatory consultant and technology partner. Meet FDA and other global health authorities' submission requirements with confidence. Reed Tech offers data conversion, publishing, electronic submissions and content management solutions for the life sciences industry.
- 网站
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https://www.reedtech.com/
LexisNexis Reed Tech的外部链接
- 所属行业
- IT 服务与咨询
- 规模
- 5,001-10,000 人
- 总部
- Horsham，Pennsylvania
- 类型
- 上市公司
- 创立
- 1961
- 领域
- UDI、Global Data Synchronization Network、SPL、LDR for Biologics、Medical Device Data Management、Drug Product Data Management、Medical Device Safety and Quality、Global UDI submissions、Drug Label Research、GUDID UDI、EUDAMED UDI、China NMPA UDI、South Korea IMDIS UDI、SaaS Life Sciences、Life Sciences、eCTD、US Agent、Medical Writing和Regulatory Compliance
产品
![点击此处查看Reed Tech SingleSource? for Medical Devices]()
Reed Tech SingleSource? for Medical Devices
数据库管理系统 (DBMS)
Maintain a master medical device product data set and provide accurate data to regulatory authorities and customers Health authorities around the globe are developing regional legislation with requirements and timelines for Unique Device Identification (UDI). Simplifying and refining complex compliance and monitoring activities allows professionals in Regulatory Affairs, Quality Assurance and IT roles to focus on the bigger picture. Bringing compliant products to the global market is simplified when you have experienced guidance on the similarities and differences among varying regulators. Gain a 'shared view' of the UDI data submitted into all the Health Authority Channels your products are marketed in with flexible role assignments for corporate and in-country representatives.
地点
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主要
获取路线
7 Walnut Ave
US，Pennsylvania，Horsham，19044
LexisNexis Reed Tech员工
动态
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Sneak Peek: Here's some of what you can look forward to learning in our upcoming LexisNexis Reed Tech Webinar | Mastering Health Canada XML PM Monographs: Insights and Strategies from LexisNexis Reed Tech Date: Thursday, March 6th | 2 PM ET Register now: https://hubs.ly/Q038tnVQ0 #HealthCanada #XMLPM #Regulatory
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?? Important Update for Pharma Professionals: Understanding FDA Inactive Products ?? Did you know that missing FDA filing deadlines can lead to your drug products being marked as inactive? This status can result in non-compliance, market removal, and potential financial losses. It's crucial to stay informed and proactive to avoid these risks. Learn more about the implications of inactive status and how to resolve it in our latest blog post. Stay compliant and safeguard your market presence! ?? Read more: https://hubs.ly/Q038gvvw0 #Pharmaceuticals #FDACompliance #RegulatoryUpdates #LexisNexisReedTech
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Considering registering for the upcoming LexisNexis Reed Tech webinar on Health Canada? Here is why you should. This is a crucial regulation for pharmaceutical companies selling in Canada, and understanding these changes is vital to maintaining compliance and market access. What will you learn? Key Takeaways: - Grasp the XML PM requirements to avoid financial and reputational risks - Learn about the key deadlines and what's required by July 18, 2025 - Discover the preparation and submission process for XML PMs - Avoid common pitfalls with insights from LexisNexis Reed Tech experts - This session is essential for staying compliant and competitive in the evolving regulatory landscape Don't miss out on this opportunity to equip your organization with the knowledge and tools needed for success! ?? Date: Thursday, March 6th ?? Time: 2 PM ET ?? Register now: https://hubs.ly/Q0381Htw0
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Did you know? LexisNexis Reed Tech is responsible for over 50% of voluntary XML PM submissions made to Health Canada. Who better to learn from than the experts? Join us Thursday, March 6th for a free, educational webinar designed to prepare drug companies for upcoming required submissions. https://hubs.ly/Q037J41R0
Mastering Health Canada XML PM Mandates: Insights and Strategies from LexisNexis Reed Tech
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WEBINAR ANNOUNCEMENT | Mastering Health Canada XML PM Mandates: Insights and Strategies from LexisNexis Reed Tech Join LexisNexis Reed Tech subject-matter experts, Gary Saner, Mary Frasch, and Dennis Lingg, for a comprehensive webinar on the newly announced Health Canada XML Product Monograph (PM) July 18, 2025 deadline, a pivotal development for pharmaceutical companies operating in Canada. Register now for this free, educational webinar: https://hubs.ly/Q037zRND0
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It's the last day of #RSIDM2025! Visit us at booth 303 and learn more about our regulatory compliance services. Our experts,?Robin Schilling,?Leia Wilhelm,?James Hilferty, and Wendy Scott, are ready and waiting for your questions.
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Join us at DIA RSIDM 2025 in Bethesda, MD, booth 303, to explore our eCTD and Compliance-as-a-Service (CaaS) solutions. Our team of experts- Wendy Scott, James Hilferty, Robin Schilling, and Leia Wilhelm- is here to answer any questions you may have about how our services can support your compliance needs. #RSIDM2025
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LexisNexis Reed Tech will be attending DIA #RSIDM25 next week! If you are attending, please stop by our booth #303 to learn about the exciting updates going on within our Life Sciences organization. To schedule time with one of our experts in advance, reach out to [email protected]. Wendy Scott, Robin Schilling, and James Hilferty are looking forward to connecting with you!
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The FDA has updated GMDN Codes compliance in the GUDID to enhance standardization and device classification. Read this blog for more information. https://hubs.ly/Q033jPCn0
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