ELECTRONIC COMMON TECHNICAL DOCUMENT

Are you an innovative pharmaceutical company faced with meeting strict requirements for Electronic Common Technical Document (eCTD) submissions as a hurdle to bringing new drugs to market? If so, Quark dynamic publishing software can help you streamline the creation, assembly, review, and submission process for both new and generic drugs.

The Costly Path to New Drug Acceptance

On average, a pharmaceutical company loses a million dollars every day that a new blockbuster drug is not released to the market. And because enormous costs are required to develop new drugs over an average of 10-15 years, anything that can speed up the process is paramount.

Yet the traditional publishing process pharmaceutical companies use to create eCTD submissions only hinders the introduction of new drugs to the market because it relies on slow, error-prone manual techniques. Pharmaceutical companies can streamline and automate the way they create, review, and publish information to speed up the submission process and bring new drugs to market faster.

Improve eCTD Preparation with Dynamic Publishing

Quark's dynamic publishing software provides a new approach for developing fast, compliant regulatory submissions.

Using Quark XML Author for Microsoft® Word, with little or no training anyone can create structured, reusable XML content in the familiar Word environment — content that can be automatically assembled and published following eCTD submission guidelines. This speeds up the entire submission process, delivers more accurate content, and can contribute to the faster introduction of new drugs to the market.

Our set of software tools:

  • Enables reuse of content through the creation of structured XML content components using Microsoft Word
  • Enables content referencing and automated content updates when the source content changes by integrating documents with existing business systems and data sources
  • Automates content integration from data sources such as databases and other corporate repositories by automatically merging that content with authored content
  • Simplifies the process of assembling hundreds of thousands of pages into submission packages by automating routine tasks such as template and metadata management, enforcement of authoring formats, and evaluation of regulatory compliance
  • Simplifies the creation of PDF documents for use in the eCTD submissions process

Our dynamic publishing solution can help you:

Speed content creation and document assembly by up to 25%
By creating structured XML content in Microsoft Word, you can automatically assemble reusable content components into documents to speed up the eCTD submission process.

Reduce cost for content creation and document assembly by up to 30%
You can take costs out of new drug development by streamlining the content creation, review, and FDA submission processes — which also improves the downstream publishing process.

Ensure regulatory compliance
Using our software, you can:

  • Develop a structured document template library that provides templates for each portion of the eCTD
  • Automatically notify authors when content does not comply with template guidelines
  • Facilitate the use of proper terminology within documents
  • Enable authors to locate and reference external sources through metadata management

Optional components include: