Common Technical Document
I have edited CTDs for tissue preparations and ATMP to support…
Scientific Advice and Audits with authorities
I have attended scientific advice meetings at EMA and PEI and…
Head of Production
I was a COO and CSO of a company and a Head of production for an ATMP. I have provided…
Coaching and mediation
As an educated coach and mediator and with my experience as a member of a management board…
Nonclinical Development
Your medicinal product is characterized by biochemical analytical methods…
Manufacturing Process
Deep knowledge of ATMP production and relevant manufacturing steps…
Manufacturing Site
If you wish to exchange views about a new production site or equipment for biological medicinal products…
Preclinical Development
I have supported clients to develop the ideal design for their animal studies…
Multicenter Trials
I have prepared and realized phase II and III multicenter clinical trials for ATMP…