Quark Enterprise Solutions for Life Sciences offers a method of compliance for increasing XML-based regulatory requirements so that new drugs may be brought to market more efficiently. The accuracy of public-facing information such as labeling is improved, increasing patient safety.
An Easy Path to XML Implementation
Quark XML Author, an add-in to Microsoft Word, allows authors to create structured content in the familiar Word environment. That content can then automatically be reused in multiple documents, assembled into publications, and published it to multiple types of media with minimal training and disruption.
- Structured Product Labeling (SPL)
The Quark SPL Accelerator for Quark XML Author is a commercial, out-of-the-box solution based on Microsoft Word for pharmaceutical, over-the-counter, animal medicine, and biologic manufacturers. Word content is converted into valid and compliant SPL files and implementation of the accelerator can be done with minimal business disruption.
- Product Information Management (PIM)
Life sciences companies must meet the PIM requirements of the European Medicines Agency (EMA). Quark partners with leading systems integrators, such as Glemser Technologies that offers a global solution for labeling, and enables authors to create complete and valid content in Microsoft Word.
- Electronic Common Technical Documents (eCTD)
Innovative pharmaceutical companies that must reduce the cost and time-to-market for documenting new drugs can implement Quark Enterprise Solutions, including Quark XML Author for Microsoft Word and Quark Publishing Platform. Content creation, approval, assembly, and publishing are streamlined, shortening negotiations with regulators (such as the FDA in the United States) and automating routine tasks as well as automatically flagging regulatory compliance problems.
XML authoring aids not only regulatory submissions, but also all formal documents required to bring new drugs to market, including marketing materials. Quark Enterprise Solutions for Life Sciences allows authors to focus their energy on creating information instead of laying out pages and applying formatting. Information reuse instead of recreation streamlines document production and maintaining a single source of assets improves accuracy as well as efficiency.