News & Events

RIM Analytics: Dashboards with a Purpose

Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring.  Effective management occurs when prioritization is risk-based, decisions are deliberate and data-driven, and activity management is holistic. What do all of these RIM activities

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Four Ways to Reduce Regulatory Risk Using RIM

If you asked a regulatory colleague about the purpose of a Regulatory Information Management (RIM) system, they might say to provide replacement for spreadsheets, consolidate regulatory information in one place, or to enable tracking and management of approvals.  They might

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FDA News: FDA Updates Various eCTD Documents

Recently, the FDA updated a number of documents related to eCTD.  These changes are summarized in the eCTD Submission Standards document, which provides a consolidated change history and links to supporting documents. Support for Modeling and Simulation.   This is an

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FDA Removes Two-Way Communication from eCTD 4.0

FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was issued without comment, and includes two components: CTD v4.0 Technical Conformance Guide (PDF) FDA eCTD v4.0

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