IQVIA Global Compliance has released 3 new tools this week aimed at improving regulatory publishing cycle times and productivity: Regulatory Templates, Regulatory PDF Tools, and the eSubmission Validator.
Regulatory Templates: These templates offer a fast, simple way to automatically generate regulatory documents. Users can choose from among 320+ regulatory shell templates through its menu-driven selection, as defined by US, EU, Swiss and Canadian regulatory agencies and the International Council on Harmonization (ICH) for both marketing and clinical trial applications. In addition, an add-in for Microsoft Office Word provides a focused toolbar with the best of Word formatting aids and a set of regulatory tools that ensure consistent tables, figures, headers and footers, plus configurable page layouts to fit your requirements.
Regulatory PDF Tools (IRPT): Ninety to ninety-five percent of electronic regulatory submissions consist of PDF documents. IRPT provides authors a suite of about thirty fit-for-purpose “wizards” that improve cycle times and lower the effort required to prepare required PDF documents. Companies benefit from the speed resulting from IPRT’s built-in intelligence and highly intuitive user interface. This industry-standard toolkit assists publishers and reviewers in preparing, publishing and delivering compliant regulatory PDF documents – addressing specific regional regulatory agency and industry requirements.
eSubmission Validator: The eSubmission Validator verifies that eCTD or NeeS submissions are in technical compliance with regional and ICH specifications and requirements prior to dispatch, thus avoiding costly delays due to refusal to file or rejection.