Electronic Regulatory Solutions

Pharmaceutical Submission Management Solutions
Newbook provides Submission Management Solutions for the pharmaceutical industry through our partnership with Lorenz Life Sciences Group. Lorenz’s docuBridge product is a mature, capable platform for both industry and reviewer organizations. Highly flexible in design, docuBridge can readily adapt to the rapidly evolving world of eCTD (electronic Common Technical Documents) submissions, providing technically compliant submissions in both paper and electronic formats from common source documents. The docuBridge Submission Management System includes its own document management system or can use an enterprise system already in place. Finally, in an environment where quality requirements are paramount, docuBridge is 21 CFR Part 11 compliant and Lorenz’s internal processes have an independent GAMP4 certification.

Newbook provides sales and support services for the Lorenz Life Sciences Group in Canada, and is ready to assist your organization with its submission management & publishing needs.

Electronic Forms Solutions
Drawing upon our experience developing custom electronic form solutions, Newbook has prepared a methodology and supporting code framework to make implementing these critical systems more effective. Newbook’s Electronic Forms Solution takes advantage of existing open standards such as XForms and Newbook’s own Solutions Framework to provide a high level of basic functionality with a minimal amount of customization. The modular architecture of the Newbook Solutions Framework simplifies the implementation of a variety of advanced features such as custom form logic and layouts, enhanced validation, 21 CFR Part 11 level auditing and logging, and event notification. The Newbook Electronic Forms Solution provides an excellent blend of cost-effective standards-based functionality and maintainability.

Structured Product Labeling Authoring
To meet the pharmaceutical industry's Structured Label requirements, Newbook offers a new product called labelBridge. This point solution, jointly developed by Newbook and Lorenz Life Sciences Group, enables full compliance to the FDA’s SPL requirements and is also designed to be easily adapted to other standards, especially the European PIM standard. More than a simple authoring tool, labelBridge provides label information management including content management, support for annotation and review processes, publishing to regulatory standards, exporting label information to various file formats beyond XML (e.g. PDF, RTF/Word), and many other features.

LabelBridge is designed to easily integrate into a modern technical environment. It is a browser-based J2EE Java application which re-uses your existing Database Management systems for its primary data storage (i.e. Oracle, SQL Server) and can integrate with other enterprise applications if required (e.g. LDAP, Documentum, SAP).

Electronic Submission Solutions
Newbook’s electronic submission solutions enable stakeholders to finalize their information set, package it and successfully transmit it to the regulator. It also supports the regulator’s requirements to track and verify incoming information for legal and audit purposes. Submission solutions typically include one or more of the following functions:

• Secure Information Gathering
• Data and Document Validation
• Integrity checking and Digital Signatures
• Transmission and Reception Solutions

Newbook’s electronic submission solutions are based upon a modular architecture. They take advantage of open standards and best of breed technologies that can easily integrate into customer environments. This approach enables a submission system to be implemented either as a client application, possibly network-aware, that provides local validation, and document preparation functionality, or as a web-based application that provides validation against a regulator’s internal databases and can be integrated with government common infrastructure services.

Publishing and Reporting Tools
Newbook Publishing and Reporting Tools are used to produce “renditions” and “views” of structured data that has been submitted electronically and that may reside in a database. The publishing tools support the production of multiple output formats, such as PDF and HTML from the same original information content. The reporting tools provide a publishing-oriented interface to relational databases. The tools are flexible and can be integrated into a larger system such as a “publish-on-demand” website, incorporated into an authoring environment to provide document previewing functionality, or run from a command line.

Electronic Regulatory Consulting & Management Services
Newbook can provide a variety of management consulting engagements to organizations that are considering electronic regulatory solutions, or are in the early stages of implementing a system. These engagements allow organizations to benefit from the extensive experience of the Electronic Regulatory Solutions Practice and provide a strong foundation for their initiatives. Engagements include:

• Strategic Planning for Electronic Regulatory Implementation
• Product/Programme Review & Assessment
• Business, Technical or Document Analysis & Architecture Assessment
• Technical Advisory Support
• Cost Benefits Analysis, Procurement Support, Project Management