The product behind the product

Consider a pair of sunglasses. The customer sees a frame, a tint, perhaps a designer’s name. A regulatory team sees another object: a collection of identifiers and attributes that must be assembled, checked and kept current. Multiply that object by thousands of products, then by the markets where they are sold. Suddenly, the unglamorous work behind the merchandise deserves its own software.

That is the territory of LexisNexis Life Sciences Solutions. The business, previously branded Reed Tech, helps medical device, pharmaceutical and cosmetics companies manage the information regulators require. Its current name joins an established operation to the wider LexisNexis identity. The company says the same experts, services and solutions continue through the transition.

The eyewear arithmetic

Kenmark Eyewear offers a useful example. In a company-published case study, the eyewear supplier described a portfolio of about 15,000 device identifiers. Susan Parker, then its director of purchasing and logistics, began by studying FDA documentation and attending Reed Tech training offered through The Vision Council.

The problem was scale. Manually moving product information into submission records would consume time the team needed elsewhere. Kenmark chose SingleSource for Medical Devices and a machine-to-machine submission route. Its own IT team built a tool to gather the required data for upload. Account-management meetings clarified the handoff.

“The UDI journey is not intuitive and not easy.”Susan Parker · Kenmark Eyewear

The case reports that most identifiers had been submitted while exceptional records received separate attention. The lesson is refreshingly practical: bring IT in early, establish a repeatable process, and give awkward cases their own workstream. A clean submission depends on work done well before submission day.

The missing field comes first

A second, anonymous customer story makes the difficulty more visible. After leaving a larger corporate infrastructure, a device business needed to rebuild datasets and processes. It had manually entered several hundred products into FDA’s Global Unique Device Identification Database, or GUDID, in 2016. The company’s account describes slow work, errors and gaps.

Some missing information lived in paper files. Some sat with specialists. Some belonged to other systems. The customer also needed current versions of records in its regulatory information database. With roughly 3,000 US stock-keeping units, it sought a cloud platform and automated submissions.

SingleSource supplied templates, validation and error messages that helped standardize the work. The customer reported smoother internal processes over five years. The first constraint, in this account, was the condition and distribution of the information. Faster transmission would have left that constraint intact.

Build once. Keep maintaining.

SingleSource for Medical Devices centralizes UDI, short for Unique Device Identification, submission data. Its features include role-based access, audit trails, version history and retained acknowledgements from authorities. These details matter because sending a record and knowing what happened to it are separate operational tasks.

The platform addresses markets including the United States, European Union, China, South Korea and Australia. Requirements differ across jurisdictions, so a shared repository still needs country-specific rules and submission channels. Commercial distribution adds another destination: product information can also travel through the Global Data Synchronization Network to trading partners.

There are simpler alternatives. FDA explicitly recommends its manual GUDID web application for a few records and HL7 Structured Product Labeling file submissions for larger volumes. A small, stable portfolio may justify direct entry. A platform becomes more relevant as records, revisions and destinations multiply.

The label becomes a database

Pharmaceutical work follows a related logic. Structured Product Labeling, or SPL, is an HL7 document standard adopted by FDA to exchange product and facility information. A readable label must become structured information that another system can process.

SingleSource for Drug Products stores product listings, establishment information and labeler data in a master submission library. Guided forms and FDA business-rule validation support preparation. The business also provides conversion and submission services, eCTD support, US Agent services and cosmetics listing assistance.

Navigator for Drug Labels turns the information outward, into research. Teams can search US and centralized EU human drug labels, compare versions and monitor changes. For a labeling specialist, the valuable unit is often a changed sentence rather than an entire document.

Partnerships extend that work. Schlafender Hase’s TVT supports content verification around label conversion. A February 2026 announcement expanded the ONIX Life Sciences alliance around eCTD and regulatory operations. LexisNexis supplies SPL expertise; ONIX brings complementary submission services.

Buying the next border

The commercial model combines SaaS with specialist services. Device customers can use the interface themselves or choose a guided Premium SaaS approach. SingleSource describes selectable market channels: customers activate and pay for them as they enter markets.

LexisNexis says pricing depends on the products, users, workflow, integrations and geographic scope involved. That makes the buying exercise a planning exercise. Which markets come first? Who prepares the source data? Who handles corrections and future changes? Those answers determine the service required and the internal effort that remains.

Its market position sits between a company’s internal product systems and the authorities or trading partners that consume their data. The combination of a maintained platform and available specialists is the proposition. Buyers should judge it against the specific work they need to transfer, including the exceptions that survive a successful software rollout.

The work behind the click

The company’s expertise reaches into standards development. Gary Saner’s published biography describes participation in HL7 SPL leadership, process and technical groups. Its website also lists project-management and software-development credentials. This is a business where interpreting a field can be as consequential as moving it.

For readers running any data-heavy operation, the transferable idea is straightforward. Assign ownership, establish current records, validate before handoff and preserve the response. Automation needs that groundwork. A repository cannot discover every missing fact in a filing cabinet. People still have to supply the truth that makes the next click useful.