NLabel, Inc.

Products

NLabel Manager

   The initial labeling product:  NLabel Manager is under development for initial use in large global companies.  NLabel Manager is a software product that can reside inside the pharmaceutical company to handle internal workflow in headquarters, and between headquarters and the multiple national affiliates.  NLabel Manager can connect to the eXchanger system for transmissions external to the company and to worldwide national regulators. 

eXchanger (available 3Q2002)

   The eXchanger system is Documentum 4i-based with the business logic layer customized to handle XML defined content, as well as documents and data.

   The main function of eXchanger is regulatory label submission and exchange.  It will be an ASP that can be a component of eDrugLabel or receive materials from NLabel Manager and related in-house EDMS and databased systems.

eDrugLabel “ MSP (available 2003)

   The flagship product:  DrugLabel a Documentum 4i e-business (compliance edition) platform-based MSP will have multiple application layers (one for each client subscriber) and multiple communication layers, including one planned to the Internet-based label disseminators (e.g.  ePDR, eMC) .   Once the initial label has been finalized, only changed sections will be transmitted. eDrugLabel will be internationally available and  support multiple natural languages.  It will be capable of accepting partially complete data records and allowing data insertions, updates, edits and deletions over extended periods of time.

   The service. NLabel, Inc. will provide a value-added system solution “molded” to efficient corporate label management processes.  Using the eDrugLabelproduct, NLabel will manage pharmaceutical product information using international technology standards.

   Annual subscriptions will be sold to pharmaceutical companies for use of eDrugLabel MSP-based software and services.  eDrugLabel will be accessed by the corporate working environment to author or receive, transform, and transmit data from in-house drug development EDMS, using  secure standard transfer protocols.  eDrugLabel will serve as a many-to-many B2B portal hub for global exchange of  labels. 

PSUR Assembler Portal (available 2003)

   The PSUR Assembler Portal will utilize intranet portal interface technology and component level document management between the corporate EDMS, internal regulatory databases and the company’s ADR reporting system.  It will serve to manage and compile validated (Part 11 compliant) Periodic Safety Update Reports (PSURs) for submission to various regulatory agencies.