Building the Future’s Structured Content Solutions… Today!

ThinSpring Meets FDA’s SPL Challenge and is First to Market with Solution

Watchung, NJ - (June 14, 2004) - ThinSpring provides the only true thin client eXtensible Markup Language (XML) editor on the market, for the management of Structured Product Labeling (SPL). This functionality was demonstrated at an FDA sponsored industry meeting June 4, 2004 at the Wiley Auditorium, College Park, MD after being one of the few companies invited to present.

SPL is an initiative that impacts every human prescription drug pharmaceutical health manufacturer marketing products in the United States. Each pharmaceutical manufacturer has an imperative to take a closer look at electronic document submissions. SPL refers to the electronic editing and submission of product labeling content, commonly known as package inserts. It is based on current industry standards. "There are competitive advantages and cost savings driving these types of initiatives. Additionally, up-to-date drug data is available faster for medical practitioners to access via the National Library of Medicine (NLM), improving public health and safety ," said Ron Celeste, president of ThinSpring.

ThinSpring SPL offerings have been crafted to allow non-technical personnel to create and manage complex documents that exploit the advantages of XML, its data reuse, data portability and data archiving abilities.

"Our SPL services and technology provide pharmaceutical and health care firms with a highly flexible and user-friendly way to achieve SPL compliance." Mr. Celeste said.

ThinSpring's SPL capabilities consist of following Extensible Markup Language (XML) based offerings:

ThinSpring SPL Server™ technology.
100 percent Web based. Only a thin client program (e.g., standard Web Browser) is required to maintain a manufacturer's labeling content.
100 percent valid Health Level 7 SPL version 1.0 registered schemas
PhRMA working group standard style sheet compliance
"What you see is what you get" (WYSIWYG) editing of label content
Electronic and digital signature x.509 encryption/decryption
Audit trails of all SPL documents

Once securely logged in, a user can perform simple and intuitive Label Editing functions, all of which fully support the current SPL formats with the ability to evolve as the standards do.

Quality Conversion Services™ (QCS)

As the name implies, this service-based offering removes the need to have pharmaceutical and animal health manufacturers contend with the challenges of converting to XML-based package insert labeling content. On an outsourced basis, the Quality Conversion Services (QCS) will interface with a manufacturer's current graphics, printing, editing, R&D, regulatory, and legal areas, collect the latest version of the labeling information and on an outsourced basis convert it into standard SPL formats. Once the new "XML wrapped" content is returned to the manufacturer, it can go through the normal quality assurance and approval cycles, and then, in the United States, as annual reports and/ or labeling changes dictate, can be submitted to the FDA.

This service is intended for all Manufacturers, those with only a few labels to those with hundreds. The Quality Conversion Services (QCS) employs a secure Web enabled infrastructure. Consulting services are also available to help address international and domestic issues, such as how to deal with natural languages (e.g., Spanish, French, Japanese, etc.), European and country specific regulatory challenges, best practice approval work flows and regulatory operations correspondence.

About ThinSpring:
ThinSpring, founded by former pharmaceutical and medical device professionals, specializes in XML web-based solutions, integration and data conversion. ThinSpring has used its industry expertise to develop a dynamic XML engine, MatriXML™. This patented XML technology is the basis for all ThinSpring solutions including XML Sage, SPL Server, PIM Server, and eCTD Server. ThinSpring’s solutions have gained acceptance as an essential, collaborative application-development platform for FDA regulated companies. ThinSpring’s core team manages technology and regulatory consulting divisions that support its clients’ operations throughout the United States, Europe, Asia and South America. ThinSpring headquarters is in Bridgewater, New Jersey, with offices in California and North Carolina. More information about ThinSpring and ThinSpring’s solutions can be found on their website at: http://www.ThinSpring.com.

Media Contact:
Ron Celeste
ThinSpring
908-962-0740
ron.celeste@thinspring.com