Trusted Data. Compliant Systems.
umk consulting is a Germany-based life sciences consultancy focused on Data Governance, Data Integrity, Computer System Validation (CSV), and AI/ML compliance in regulated GxP environments.
The company supports pharmaceutical, biotech, medical device, and healthcare organizations in implementing pragmatic and risk-based compliance solutions aligned with global regulatory expectations including EU GMP, FDA, PIC/S, ICH, and GAMP guidance.
Dr. Ulrich Köllisch is the founder of umk Consulting and an internationally recognized expert in Data Integrity, Data Governance, CSV, and AI/ML compliance in the life sciences industry.
He has more than 10 years of experience supporting pharmaceutical and biotech organizations in implementing compliant and pragmatic quality and digitalization strategies.
He is actively involved in leading industry organizations including the Parenteral Drug Association, where he serves as Co-Head of the Special Interest Group on Data Integrity and Data Governance and contributes to multiple regulatory and technical initiatives.
Begin Your Transformation
Submit the inquiry form to discuss your objectives and determine how a tailored consulting engagement can advance your strategic priorities.