Dr. Busch Regulatory Strategy GmbH Regulatory affairs consultancy and support for biomedicines We are located near Hamburg and focussed on biomedicinal pharmaceuticals in Europe: advanced therapy medicinal products (ATMP): gene therapy, somatic cell therapy, tissue engineered products, xenogeneic medicinal products tissue preparations stem cell preparations blood products transplants immunoglobulins or antibodies for the treatment of oncological, neurological or autoimmune diseases (or other indications) vaccines therapeutic and diagnostic allergens Dr. Gudrun Busch is the founder and owner of the Dr. Busch Regulatory Strategy GmbH. Besides 9 years of experience in research and lecture of molecular cell biology at the Universities of Hamburg and Berlin, she has long-lasting experience and a proven track record in successful international registrations of biological pharmaceuticals , but also medical devices and chemical drugs.