“Dr. Krahl supported Takeda twice successfully as Interim Manager for our Regulatory Affairs Department and as Interim Head of our Compliance Department. We appreciated her highly efficient management skills and deep knowledge of regulatory affairs and compliance matters”

“Ute trained our Cellex QA team focused and with great commitment in the practical implementation of the legal requirements for quality assurance. This was done using actual examples of GxP compliant documentation of non-conformance, change control and general quality compliant documentation. Continued hands-on training of the team resulted in increased empowerment and professionalism of the QA team. The corresponding improvement in quality processes led to a measurable increase in QA compliance. ”

“Working with BioReg was an absolute pleasure. We undertook a very complex acquisition of a manufacturing site, FDA approved vaccine and numerous other assets. Ute and her team were instrumental from initial diligence, to helping define the assets to purchase, to developing the quality and regulatory integration plan and delivering the initial Quality System for the new organization. A big success, this acquisition, only possible with BioReg’s assistance, transformed our company.”

“During the development phases of our vaccine candidates and biotechnological products Dr. Ute Krahl has been providing very valuable strategic advice in manufacturing and regulatory affairs matters. With her excellent strategic and hands-on support to the team VPM managed to develop a live recombinant vaccine from bench to man in less than four years.”

“Dr. Krahl is a highly reliable and fully dedicated advisor for Regulatory Affairs and a much-valued partner of our development team that successfully moved our lead product – a monoclonal antibody construct - from research into clinical trials Phase I and Phase II in the EU and the USA.”

“Dr Krahl supports our Regulatory Affairs department and our quality team as a highly valued consultant who provides efficient and accurate assessments of issues within a short time frame.”

“Ute supports the PPTA as very experienced auditor and as engaged ambassador to the International Quality Plasma Program in Europe since two decades.”