Microsystems Solutions for Life Sciences

Pharmaceutical and biotech companies are under increasing pressure to streamline the NDA submissions process. Large investments in document management systems, better work flow processes, e-trial solutions and advanced publishing systems yield overall process and document quality improvements. But they do relatively little to address the day-to-day document problems that can commonly derail or delay submissions.

Produce Higher-Quality Submission Documents Faster

Microsystems document production solutions help regulatory operations professionals, medical writers, and IT support teams at leading life sciences companies produce higher-quality submission documents faster. Streamline your FDA filing process while increasing submissions document quality using the time-tested capabilities of Knowledge Partnership.

Address pressing submission document issues with proven solutions, including:

• Automated document QA — Proactively create submission-ready Word documents that render as healthy PDF documents to meet tight submission deadlines.
• Template compliance — Check submission documents against proprietary formatting standards in order to ensure their conformance.
• PDF readiness check — Automatically check the ability of documents to render properly to PDF. Identify and resolve errors prior to final rendering, eliminating the trial and error method of rendering to PDF.
• Content quality control — Discover what metadata and other high-risk content lies beneath your documents. Automate the analysis of Microsoft Word and PDF documents to reduce risk at every stage of the submission process.
• Submissions quality check — Automate the identification of the most common document errors that could adversely affect your final submission.

To learn more, please contact us, or request a Document Assessment to help you understand how the Knowledge Partnership for Life Sciences can help you solve your document challenges.