Über uns

Focused on operational excellence, we assist companies improve decisively the entire life-cycle of their products and processes with our unique capabilities and proprietary strategies in:

· Lifecycle Management (CPV) using massive amounts of process and quality data, from development and/or manufacturing.

· End-to-End Analysis (advanced CAPA) for Troubleshooting & Increased Process/Product Knowledge.

· Extracting much more from already existing & paid data: Bioanalytics, Bioengineering and Pharmacological Performance Data.

· Proactive Implementation of New Regulatory Initiatives: Quality Risk Management (QRM), Comparability of BioProducts Subject to Changes in Manufacturing and 'Established Conditions’ to revised Quality Commitments.

We also provide software solutions designed for operational excellence.

· iRISK - A risk-assessment and risk-management tool to summarise experts prior knowledge (Prior-K) and investigate, quantify and prioritise risks for new or existing processes throughout the life-cycle (www.iRisk.com)

· iSEE -  Capture and access consistent data, analyze and monitor information and share knowledge to support process & product improvement. (www.iSeePlatform.com)