Reed Tech
Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies, specializing in UDI data management and SPL services for global health authorities.
LexisNexis Reed Tech is a leading provider of information-based solutions and services for the Life Sciences industry. They specialize in managing medical device Unique Device Identification (UDI) product data for global health authorities, offering expertise in UDI data submission and product lifecycle management. Their services include outsourced Structured Product Labeling (SPL) for US FDA product listings, eCTD, US Agent services, and other drug listing & establishment registration services. Reed Tech serves a wide range of clients, from small to mid-size producers and distributors to the largest global leaders in the pharmaceutical and medical device sectors. With a focus on regulatory compliance and data accuracy, Reed Tech's SingleSource™ platform for Medical Devices ensures UDI data is managed in a compliant SaaS environment, with scalability for increased volume and global health authorities. They actively support UDI channels for US FDA, China NMPA, South Korea MFDS, and are staging for EU EUDAMED and Australia UDID, demonstrating their commitment to global regulatory support.
About
**Who they are**
Reed Tech, a LexisNexis company, offers product and service solutions designed to help Life Sciences professionals manage their data. They cater to a wide range of customers, from small to mid-size producers and distributors of pharmaceutical and medical device products to large global leaders.
**Expertise & scope**
* Core business is managing medical device Unique Device Identification (UDI) product data for global health authorities.
* Provides regulatory solutions for medical device and pharmaceutical companies.
* Specializes in UDI data management and SPL services for global health authorities.
* Offers MedTech Regulatory Solutions, Product Data Management, and Unique Device Identification (UDI).
* Provides Pharma Professional Services including SPL & XML Services, Drug Data Management, Drug Label Research & Analytics, eCTD Services, Health Canada XML PM, and US Agent services.
* Supports the collection, transformation, submission, and analysis of regulatory data for manufacturers, distributors, and supporting IT roles.
**Reputation / proof points**
* Serves a customer base ranging from small to mid-size producers and distributors to the largest global leaders in pharmaceutical and medical device products.
Reed Tech, a LexisNexis company, offers product and service solutions designed to help Life Sciences professionals manage their data. They cater to a wide range of customers, from small to mid-size producers and distributors of pharmaceutical and medical device products to large global leaders.
**Expertise & scope**
* Core business is managing medical device Unique Device Identification (UDI) product data for global health authorities.
* Provides regulatory solutions for medical device and pharmaceutical companies.
* Specializes in UDI data management and SPL services for global health authorities.
* Offers MedTech Regulatory Solutions, Product Data Management, and Unique Device Identification (UDI).
* Provides Pharma Professional Services including SPL & XML Services, Drug Data Management, Drug Label Research & Analytics, eCTD Services, Health Canada XML PM, and US Agent services.
* Supports the collection, transformation, submission, and analysis of regulatory data for manufacturers, distributors, and supporting IT roles.
**Reputation / proof points**
* Serves a customer base ranging from small to mid-size producers and distributors to the largest global leaders in pharmaceutical and medical device products.
Additional information
Reed Tech's services are structured to streamline regulatory data management for life sciences companies. Their offerings facilitate the entire lifecycle of data, from collection and transformation to submission and analysis. This is particularly relevant for companies navigating complex global health authority requirements, such as UDI data management for medical devices and SPL services for pharmaceuticals. Buyers can expect solutions tailored to both product data management and the submission processes required by various regulatory bodies. Their expertise extends to supporting various product types including medical devices, Rx, OTC, and biologics.
Key Highlights
-
Core business is managing medical device Unique Device Identification (UDI) product data for global health authorities.
Source
“Our core business is managing medical deviceUnique Device Identification (UDI) product data for global health authorities.”
-
Provides expert regulatory solutions for medical device and pharmaceutical companies, specializing in UDI data management and SPL services.
Source
“Reed Tech provides expert regulatory solutions for medical device and pharmaceutical companies, specializing in UDI data management and SPL services for global health authorities.”
-
Supports the collection, transformation, submission, and analysis of regulatory data for life sciences professionals.
Source
“Our offerings smooth the collection, transformation, submission, and analysis of regulatory data for manufacturers and distributors or medical device and drug products and for those who support them in consulting and IT roles.”
Certifications & Trust Signals
-
Part of LexisNexis, a global leader in legal and regulatory information and analytics.
Source
“LexisNexis Reed Tech | About Us”
Buyer Snapshot
Best for
- Medical device manufacturers and distributors
- Pharmaceutical companies
- Companies needing UDI data management
- Organizations requiring SPL services
How engagement typically works
- Solution-oriented service provider
- Data management and submission support
Typical deliverables
- UDI data management solutions
- SPL and XML services
- Regulatory data submission support
- Product data management
Good to know
- Best when requiring specialized regulatory data management for medical devices and pharmaceuticals.
HQ:
Horsham, US
Languages:
English
Timezones:
America/New_York
Status:
listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
DE, AT, IE, SE, DK, FR, ES
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
2–14 days
Pricing model:
Retainer
Starting from:
USD 6,000
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
UDI/Devices
Supports Training Enablement:
No
Data Load Support Level:
Done-for-you
Turnaround SLA:
Custom
eifu_platform
eudamed_onboarding_support
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
No specific onboarding steps mentioned.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
UDI/Devices
Supports Actor Registration
No
Supports UDI
Yes
Supports Vigilance
No
Supports Clinical Investigations
No
