Team

Managing Director

Moritz Hartl

Moritz has over 20 years of experience in the pharmaceutical industry. He worked for many years in business development and sales in the sector, among others as an Area Sales Manager for Medichem, S.A., Spain, one of the world´s well-known API manufacturers. Moreover, he`s an expert in supply chain, sourcing & strategic purchasing, leading for several years the Global Sourcing and Strategic Purchasing of Acino Pharma AG, a Swiss speciality pharma company. Moritz has an extensive and global network in pharmaceuticals and related industries and holds a degree in Business Administration from European University in Barcelona, Spain.

Senior Expert Regulatory Affairs

Kirstin Bauer

Kirstin holds the German degree Pharmacy Technician (PTA) and has more than 14 years of experience in pharmaceuticals and related sectors, out of which she worked nine years in Regulatory Affairs (RA). She gained her expertise working, among others for Johnson&Johnson, Beiersdorf and BODE Chemie. Within the field of RA she is a recognized expert in small molecule-drugs. Her areas of competence are CMC, labeling, regulatory strategy, dossier compilation, handling of variations and submissions. She has a big network and well-established contacts at the major regulatory authorities. Kirstin is fluent in German and English.

Senior Expert Regulatory Affairs & Quality Management

Heidi Birkmayer-Asali

Heidi holds a diploma in Pharmacy and a master of science in Pharmaceutical Quality Management, both from the University of Vienna, Austria. Moreover she has a state-permit for the trade with pharmaceutical and medicinal products in Austria. She has over 12 years of experience in Regulatory Affairs (RA), Pharmacovigiliance and Quality Management (QM). In her career Heidi worked as Head of RA for Pharmaselect International and Cyathus Exquirere, both pharma companies with a strong focus on R&D. As a freelancer she had numerous RA- and QM-assignments with well-known multinationals such as Merck KGaA, Astellas, Abbvie and CSL Behring, to name a few. Heidi has an excellent network and profound contacts with the major regulatory authorities and is fluent in German and English.

Senior Expert Regulatory Affairs

Elhem Sbaa

Elhem holds a Ph.D. in Biology from the University of Rouen, France and did her post-doctorate at UCL in Brussels, Belgium. During her career Elhem has worked for more than 13 years in the research of stem cell therapies and in tissue engineering. She has more than 12 years of expertise in Regulatory Affairs (RA) in the fields of biologicals, medical devices and finished pharma products. Elhem worked as a member of the educational group of the Belgium Regulatory Affairs Society (BRAS). Moreover she was heading the RA department at Keyrus Biopharma, an international contract research organization, for 9 years. Previously, she was team leader for Health Economic Publications at GSKBio. Before that, she was a RA associate and medical writer at SGS Life Science. Elhem also worked for several years at TiGenix, a biotech company on an Advanced Therapy Medicinal Product (ATMP). Elhem is fluent in French, English and Arabic.