Pharmaceutical e-Submission Management & Publishing
The pharmaceutical industry is well-known for its stringent regulatory oversight, leading to large complex submissions to multiple regulatory organizations. Managing these submissions requires a combination of document and records management, paper and electronic publishing and specific industry knowledge. Reviewing these submissions inside the regulatory agency requires powerful viewing, annotation and management expertise.

Newbook provides an e-Submission preparation and reviewing system solution for the pharmaceutical arena through our partnership with Lorenz Life Sciences Group. Lorenz’s docuBridge product is a mature capable and validated platform for both industry and reviewer organizations alike. 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 and providing powerful reviewing capabilities.

Structured Data Gathering (Electronic Forms)
Many organizations are gathering data online using Internet-based forms which can be a very simple and economical way to collect data. For regulatory organizations, the combination of business and legal requirements in terms of how the data collected will need to be managed and processed can make online form needs more complex. Regulatory data typically has some potential of being “evidence” for possible legal proceedings, and can therefore have higher standards in terms of security. Also, the information often requires internal processing, including analysis, reports and selective publishing.

Newbook has extensive experience with developing and supporting online form systems for regulatory environments, using leading edge XML-based forms in secure environments. Further, our projects have emphasized the collection of structured data, using XML, which can then be more easily managed and processed by internal systems.

Structured Document Preparation
For many organizations, the information they require is primarily text documents, as opposed to data that fits easily into a spreadsheet or a database. Some of these organizations have strong evidentiary requirements, and also need to process and re-purpose the content over an extended life-cycle. In these situations the use of structured documents may be suitable, using XML (or its precursor, SGML) according to pre-defined structures.

Using structured documents can require significant up-front investments, but can provide long-term benefits to a degree not found in any proprietary document format. Newbook is one of the few organizations in Canada with experience preparing, managing and publishing complex structured documents in a regulatory environment.

Regulatory Submission Systems
A key aspect of any electronic filing system is the submission component, which controls what information is submitted into the system and how it gets there. For many regulatory environments, this is particularly important due to the requirements to track and verify incoming information for legal and audit purposes. These systems typically include Validation and Security features as well as more obvious Transmission and Reception capabilities.

Newbook has had a number of opportunities to develop and support Submission systems. Newbook has particular experience in the content validation area, applying business rules well beyond the simple “does it meet the DTD” standard, including rules-based content validation, link checking, version checking, etc.

Structured Information Publishing
Once structured information has been prepared and filed successfully, the regulatory organization needs to access and view it. This often leads to publication requirements, often with multiple formats and media being prepared from the same original source content. Newbook has extensive experience in this area related to Regulatory systems, and also draws upon the resources of its Technical Publishing Practice (see TPS).

e-Filing Design & Management Services
Developing these systems requires significant advance preparation and ongoing support. Newbook has experience with Regulatory systems from the initial conceptual stages to maintenance. To this end, Newbook provides the following services:

• Business Requirements Specifications
• Strategic Planning & Cost Benefit Analyses
• Functional Requirements Specifications
• Document Analysis & SGML/XML DTD/Schema Design & Development
• Technology Architecture and Design & Infrastructure Planning
• Stakeholder Consultations & Management
• Change Management & Project Management
• Procurement Support
• Product/Programme Review & Assessment

Pharmaceutical Agencies & Organizations
Canada’s primary health standards organisation, affiliated with the World Health Organisation, produces an extensive number of publications and reports related to health information, classification coding, and statistics. Newbook undertook an information architecture analysis, then designed and developed an XML-based information system used for data collection, management, and output delivery to print, CD-ROM, and the Web. Newbook also reviewed the organisation’s extensive number of medical indexes for use as taxonomies in knowledge management systems.

Newbook is currently assisting one of Canada’s largest pharmaceutical corporations with the implementation of systems to prepare and publish paper and electronic submissions related to the pharmaceutical regulatory processes, using Lorenz’s docuBridge product.

Energy Sector Agencies & Organizations
According to independent reviews, a major energy regulator has developed one of the most sophisticated electronic filing systems in use. Predicated entirely upon the use of structured information, including documents, this system required significant innovation. Newbook assisted in various areas of its development, including Authoring Tools, Submission & Validation sub-systems and Publishing (Rendering) engines.