Podcast
Questions and Answers
What is the core business of LexisNexis Reed Tech?
What is the core business of LexisNexis Reed Tech?
When will Health Canada require the use of XML PM submissions for certain types?
When will Health Canada require the use of XML PM submissions for certain types?
Which organization modified the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS)?
Which organization modified the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS)?
What is one benefit of Unique Device Identification (UDI) regulations?
What is one benefit of Unique Device Identification (UDI) regulations?
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What advantage do the software solutions from Reed Tech offer to its clients?
What advantage do the software solutions from Reed Tech offer to its clients?
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Which type of services does LexisNexis Reed Tech provide specifically for US FDA product listings?
Which type of services does LexisNexis Reed Tech provide specifically for US FDA product listings?
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What issue did Cadwell face that prompted them to seek help from Reed Tech?
What issue did Cadwell face that prompted them to seek help from Reed Tech?
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How do Reed Tech’s customers describe their customer service?
How do Reed Tech’s customers describe their customer service?
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Study Notes
LexisNexis Reed Tech Services
- LexisNexis Reed Tech serves pharmaceutical labelers and medical device manufacturers globally, from small to large companies.
- Their solutions aim to boost productivity, ensure regulatory compliance, and facilitate quicker decision-making.
- Core business revolves around managing Unique Device Identification (UDI) product data for global health authorities.
- Offers regulatory consulting, outsourced Structured Product Labeling (SPL) services for US FDA listings, eCTD, US Agent services, and drug/establishment registrations.
Health Canada's XML PM Implementation
- Health Canada mandates the use of XML product monographs (XML PM) for submissions.
- Implementation occurs in phases, with the first phase commencing July 18, 2025.
- Initial phase requires specific submission types to include XML PM upon filing.
FDA's Opioid Analgesic REMS Modification
- The FDA approved a modified Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) on October 31, 2024.
UDI Regulations and Benefits
- Unique Device Identification (UDI) regulations are prioritized by global health authorities.
- These regulations enhance patient safety, improve supply chain management, and facilitate efficient medical device recalls.
Customer Testimonials
- Reed Tech is praised for exceptional customer service, technical support, and partnership approach.
- Customers highlight expertise in Drug Listing and UDI, along with reliable guidance.
- Customers credit Reed Tech's team with consistently successful SPL generation.
Cadwell's Data Management Needs
- Cadwell needed to streamline medical device data submissions due to multiple health authorities, regions, and divisions involved.
- They sought to gain control over dispersed data sources (spreadsheets).
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Description
This quiz covers key aspects of regulatory compliance in the pharmaceutical and medical device industries, including the roles of LexisNexis Reed Tech, Health Canada's XML PM requirements, and the FDA's recent modifications to opioid analgesic REMS. Test your knowledge on how these regulations impact product submissions and safety protocols.
