iRISKTM is a consequence of our decade-long experience delivering Quality Risk Management projects to the industry worldwide. Our QRM Team has a vast knowledge on how QRM must be applied in the demanding context of the pharmaceutical industry.
End-to-end process Risk Assessments
QRM application for the 3 Stages of Product & Process Development
Stage 1 – Design and Development
Stage 2 – Equipment & Process Performance Qualification
Stage 3 – Continued Process Verification
Seamless transfers between Lifecycle Stages
Retrospective QbD for legacy products
Risk-based Supplier Sourcing & Qualifications
QRM specialists are available to answer your questions and help you.