I possess a Diploma in Biology from Universidad Central de Venezuela and M.Sc. in Biomedical Engineering from Boston University. I have worked for both European and American companies: Baxter (Diagnostics and Haemoglobin Therapeutics), Dade Diagnostics (now Siemens Healthcare Diagnostics), Genetics Institute/Wyeth (now Pfizer). In 2002, I co-founded a regulatory affairs consultancy company in Munich and in 2007 I became a freelancer.
I have over 24 years experience in diagnostics, clinical development and regulatory affairs, in addition to specific expertise in orphan drug designations, clinical trial applications, product information, promotional materials and publication strategy for medicinal products.
As a consultant I have worked for several small biotech USA and European companies as well as large companies such as Bayer Schering AG, Medtronic BioPharma and several Contract Research Organizations (CRO).
In addition to licensing medicines through the European Medicine Agency, I have provided expert support to companies in regulatory matters specific to Germany, France, Belgium, Italy and Spain.
I speak fluently Spanish, French, German and English.