Reed Tech

Name

Reed Tech

Legal name

Reed Technology and Information Services, LLC

Website

https://reedtech.com

Company type

Private

Founded year

1961

Operating status

Operating

Headcount range

251–500 employees

Ownership category

akta.pro rank

Product category

Regulatory Compliance Software

NAICS

Software Publishers (5132), Software Publishers (513210), Other Scientific and Technical Consulting Services (54169)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

DTx/SaMD Regulatory, Quality & Compliance Software (QMS/ISO/FDA) (HLACANAN)

Keywords

• Regulatory data management
• Medical device UDI submissions
• Pharmaceutical SPL services
• FDA compliance software
• Life sciences regulatory solutions

Headquarters

HQ city

Horsham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. SaaS Software Subscriptions: Subscription-based access to SingleSource™ platforms for Medical Devices and Drug Products, providing cloud-based regulatory data management, validation, and submission capabilities. Customers pay to activate and use channels when entering markets.
2. Professional Regulatory Services: Regulatory consulting and advisory services including UDI compliance advisory, gap assessments, training, technical support, and strategic road map development. Offered at Basic, Advanced, and Strategic service levels with defined hour allocations.
3. Drug Labeling and Listing Services: Conversion and submission services for FDA SPL, drug listing, establishment registration, NDC labeler code registration, annual certifications, and related regulatory submissions. Includes proofreading services through alliance partner Schlafender Hase.
4. eCTD Services: Electronic Common Technical Document preparation, publishing, review, and submission services for FDA, EMA, and other health authorities. Includes strategy consulting, project management, validation troubleshooting, and transmission services.
5. US Agent Services: Acting as mandatory domestic representative for foreign pharmaceutical establishments, facilitating communication between foreign manufacturers and the FDA.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

Reed Tech provides cloud-based SaaS regulatory data management platforms and professional services that help medical device and pharmaceutical companies prepare, submit, and maintain regulatory filings with global health authorities. Its core offerings include SingleSource™ for Medical Devices (UDI submissions to FDA GUDID, EU EUDAMED, China NMPA, South Korea MFDS, Australia AusUDID) and SingleSource™ for Drug Products (FDA SPL-based drug listing), supplemented by eCTD publishing, Navigator™ drug label analytics, and Health Canada XML Product Monograph services.

Product overview

Reed Tech (LexisNexis Life Sciences Solutions) operates as a dual-platform company offering two core SaaS products—SingleSource™ for Medical Devices and SingleSource™ for Drug Products—complemented by specialized service offerings and a partner ecosystem. SingleSource™ for Medical Devices is a cloud-based UDI data management and submission platform supporting multiple global health authority channels (FDA GUDID, EU EUDAMED, China NMPA, South Korea MFDS, Australia AusUDID). SingleSource™ for Drug Products is an FDA-focused drug product data management system with SPL generation capabilities. Supporting services include SPL/XML conversion, eCTD publishing, Navigator™ for Drug Labels (research/analytics), Health Canada XML PM services, US Agent representation, MoCRA cosmetics compliance, and MedTech Regulatory Compliance advisory with tiered service levels. The Life Sciences Alliance connects customers to specialized partners for QMS, proofreading (via Schlafender Hase TVT), regulatory intelligence, and RIMS solutions.

Differentiator

Problem solved

Functional benefit

Brands

• SingleSource for Drug Products: Web-based application for FDA human prescription, over-the-counter and animal drug product submissions data in Structured Product Labeling (SPL) format
• SingleSource for Medical Devices
• Navigator for Drug Labels

Products and services

• SingleSource™ for Medical Devices Cloud-based SaaS platform for managing and submitting Unique Device Identification (UDI) product data to global health authorities including US FDA GUDID, EU EUDAMED, China NMPA, South Korea MFDS, and Australia AusUDID. Centralizes UDI data with machine-to-machine submission, validation, audit trails, and version control capabilities.
• SingleSource™ for Drug Products Web-based 21 CFR Part 11 compliant FDA drug product data management application for collecting and storing global product listing, establishment facility, and labeler company data in SPL format with on-demand SPL generation capabilities for prescription, OTC, and animal drug products.
• Navigator™ for Drug Labels Drug label research and analytics platform combining US and centralized EU human drug label databases with advanced search, comparison, analysis, and alert tools. Searches nearly 500,000 drug labels including branded/generic Rx, biologics, OTC, homeopathic, and herbal products.
• SPL & XML Services Structured Product Labeling (SPL) conversion and FDA submission services for prescription, over-the-counter, and biologic drug products. Includes electronic drug registration, listing, FDA conversion, and submission services with guaranteed accuracy.
• eCTD Services Electronic Common Technical Document submission publishing services including eCTD strategy, project management, compilation, validation troubleshooting, and 100% validated submission transmission to FDA, EMA, CESP, MHRA and other health authorities.
• MedTech Regulatory Compliance Services Regulatory compliance advisory and UDI implementation services with tiered Service Level options (Basic, Advanced, Strategic) providing dedicated project leads, training hours, technical support, regulatory advisory services, and gap assessments for global health authority submissions.
• Health Canada XML Product Monograph Services End-to-end support for Health Canada XML Product Monograph compliance including authoring, medical writing, labeling migration, XML preparation, eCTD support, data validation, and version storage.
• US Agent Services Mandatory domestic representative services for foreign establishments, facilitating communication between foreign manufacturers and the FDA for regulatory compliance.
• Cosmetics Facility Registration and Product Listing Services (MoCRA) Modernization of Cosmetics Regulation Act (MoCRA) compliance services including facility registration and product listing for cosmetic companies.

Quantifiable outcome

• 99.95% of pharma FDA SPL submissions delivered within contracted time
• +4 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature6 records

Partnerships

Nine partnerships are on record, tiered core and secondary.

• 1WorldSynccoreTechnology or Integration · 12 September 2024Renewed collaboration between LexisNexis Reed Tech and 1WorldSync to enable global medical device manufacturers to manage regulatory UDI submissions and product data syndication. The partnership links UDI data management with GDSN for sharing information with downstream customers and hospital networks.
• RegDeskcoreTechnology or Integration · 25 May 2023Collaboration between leading providers of Unique Device Identification (UDI) for global health authorities and RIMS compliance platform. Supports global medical device companies in managing both UDI submissions and regulatory information management.
• Schlafender HasecoreTechnology or Integration · 26 April 2022Alliance between Reed Tech and Schlafender Hase, the market leader for intelligent automated proofreading software (TVT - Text Verification Tool). Ensures data quality and compliance for pharmaceutical labeling by comparing Word to PDF and PDF to XML files.
• Greenlight GurucoreStrategic or Co-development Partner · 24 March 2022Strategic alliance between LexisNexis Reed Tech and Greenlight Guru, the leading Medical Device Success Platform. Combines UDI submission expertise with Quality Management System (QMS) solutions to guide medical device customers to market faster.
• ONIX Life SciencessecondaryImplementation/ SI/ Consulting Partner · 14 February 2022Strategic alliance between Reed Tech and ONIX, a boutique regulatory affairs and operations consultancy. Supports global eCTD submissions by combining regulatory expertise with submission technology.
• Dental Trade AlliancesecondaryGTM or Marketing Partner · 1 September 2021Recognized by the Dental Trade Alliance as a solution provider for Unique Device Identification (UDI) to U.S. FDA and other global health authorities.
• The Vision CouncilsecondaryGTM or Marketing Partner · 1 February 2021Recognized by The Vision Council as the preferred full-service solution for Unique Device Identification (UDI) to US FDA and other global regulators. Collaboration through industry association for member education and UDI compliance support.
• BH Consulting ServicessecondaryImplementation/ SI/ Consulting PartnerMember of the Life Sciences Alliance providing specialized regulatory consulting services for medical device and pharmaceutical compliance.
• Hello CanopysecondaryStrategic or Co-development PartnerLife Sciences Alliance member providing specialized services in regulatory intelligence and standards management.

Scale indicators11 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• Veeva Systems: Veeva is the largest pure-play life sciences cloud software company, offering Vault RIM (Regulatory Information Management), Vault QualityDocs, and submission management capabilities that directly overlap with Reed Tech's SingleSource and eCTD services for pharmaceutical and medical device manufacturers.
• IQVIA: IQVIA provides a broad portfolio of life sciences technology and services including regulatory solutions, R&D, and commercial analytics for pharma/biotech, with overlapping capability in submission management and regulatory consulting for the same buyer personas as Reed Tech.
• Oracle Health Sciences (Oracle Clinical & Regulatory): Oracle offers a suite of clinical and regulatory solutions including Oracle Argus Safety, Oracle Clinical One, and regulatory information management, providing enterprise-scale alternative to Reed Tech's SPL and submission services for large pharma manufacturers.
• Sparta Systems (Honeywell): Sparta Systems, now part of Honeywell, provides TrackWise quality management software widely used in life sciences manufacturing, with regulatory and compliance workflow overlap with Reed Tech's regulatory data management offerings.

Direct peers

• ArisGlobal: ArisGlobal provides LifeSphere Regulatory, an end-to-end RIM platform for IDMP, submission management, and health authority correspondence, directly competing with Reed Tech's SPL/UDI submission offerings for pharma and med device manufacturers.
• MasterControl: MasterControl offers QMS, regulatory, and document management software widely used by medical device manufacturers, overlapping with Reed Tech's UDI submission services and competing for the same regulatory affairs buyer within med device companies.

Emerging players

• RegDesk: RegDesk provides AI-powered regulatory intelligence and RIMS for medical device and pharma companies, and is an active Reed Tech alliance partner. Despite the partnership, RegDesk's regulatory intelligence and compliance workflows directly intersect with Reed Tech's submission and advisory services.
• Greenlight Guru (a MasterControl company): Greenlight Guru provides a Medical Device Success Platform with QMS, design controls, and submission management, and is a Reed Tech alliance partner via the Life Sciences Alliance. The combined QMS-plus-UDI offering competes for the same medical device regulatory affairs budget.
• 1WorldSync: 1WorldSync is the leading GDSN data pool operator and Reed Tech alliance partner, enabling product data syndication that complements UDI submissions. The integration enables joint go-to-market but 1WorldSync's data syndication capabilities overlap with Reed Tech's commercial product data management.

Others

• Schlafender Hase: Schlafender Hase provides the TVT (Text Verification Tool) for automated proofreading of pharmaceutical labeling documents and is integrated into Reed Tech's SPL workflow. While a partner, Schlafender Hase's proofreading capabilities represent an adjacent technology layer in the regulatory submission value chain.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/ReedTechLifeSci
• YouTubeyoutube.com/c/Reedtech
• LinkedInlinkedin.com/company/reed-tech-life-sciences

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Reed Tech