Boost your regulatory productivity.

Today’s stringent, global regulatory environment is exacting. And staying in compliance is an on-going, time-consuming series of activities. IQVIA Productivity Tools make it easy to rapidly prepare, publish and validate eCTD and non-eCTD electronic submissions to regulatory authorities, giving your regulatory staff valuable time back for higher-level activities.

Improve your cycle times with IQVIA Regulatory Productivity Tools

Our research shows that ‘getting it right’ is a leading concern of regulatory professionals. 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

Create the right new regulatory document every time

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

Publish PDF files faster and easier

Specifically designed for the life sciences industry, IQVIA Regulatory PDF Tools provide customers with a simple, practical way to prepare PDF documents for submission.

• Assists publishers and reviewers in preparing, publishing and delivering regulatory PDF documents
• Addresses specific needs in accordance with regulatory agency and industry requirements.
• Among fastest, most efficient PDF tools in the industry due to built-in intelligence and intuitive user interface

Assure technical compliance with regulatory agencies around the world

IQVIA eSubmission Validator verifies electronic Common Technical Documents (eCTD) and Non-eCTD Electronic Submissions (NeeS) documents, ensuring compliance with regional and ICH specifications and requirements prior to dispatch.

• Validate compliance before submitting your document(s) to a specific agency, minimizing the risk of refusal to file or rejection due to technical issues
• Receive a confidential report at the end of each validation