IQVIA’s Productivity Tools make authoring and PDF publishing easy, fast and efficient. And our validation tool ensures that what you submit is in technical compliance with health authority requirements.

• Prepare, publish, and validate eCTD and Non-eCTD e-submissions.

• Increase efficiency and reduce infrastructure development cost.

• Optimize cycle times with well-designed tools and intuitive interface.

Select the right shell document for your regulatory work with IQVIA Regulatory Templates. Right down to the specific region, module and document type required.

• Simple, menu-driven system provides quick start for regulatory authoring.

• Over 320 shell documents defined by regulatory agencies and the ICH (International Council for Harmonization).

• Cover the marketing and clinical trial application processes for submission to EU’s EMA, U.S. FDA, Swissmedic and Health Canada.

• Includes regulatory-specific add-in for Microsoft® Office Word.

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