Dr. Ingrid Huber-Strubl

Ingrid, founder and CEO of ARAC, is a pharmaceutical industry professional with more than 30 years of experience. In her career, she has supported many pharmaceutical companies within several areas in regulatory affairs and has supported a lot of pharmaceutical companies getting their licenses granted by the national competent authorities in Austria by building up the Quality Management System and supporting in all additional requirements. Ingrid has a PhD degree in Zoology and Biochemistry from the University of Vienna, has a degree as academic advertising merchant and has been in the board of MEGRA.

Regulatory Affairs, QM Systems, Inspections, Licenses

Mag. Thomas Messner

Thomas holds a master degree (Mag. rer. nat.) in Zoology and has started his Pricing and Reimbursement journey in 2003 as a consultant in the pharmaceutical area where he fully established the Pricing and Reimbursement (P&R) department from the ground up. In 2007 he became one of the co-founders and shareholders of ARAC. Since then he is the head of the well grown P&R department and supports our customers with his constantly extending experiences in market access and Pricing & Reimbursement. Thomas’ core competencies lie in strategic planning and implementation of the necessities for successful applications in the whole range of medicinal products eligible for reimbursement with the sickness fund. His strong leadership in cooperation with the sickness fund is well appreciated from our satisfied clients.

Market Access

Dr. Christian Schantel

Christian is one of the four co-founders and shareholders of ARAC. He studied veterinary medicine and after his doctor’s degree, he found his passion in safety. Christian started in the field of feed safety followed by food safety and switched finally to drug safety in the pharmaceutical industry. He shares his expertise to pharmaceutical companies in all aspects of pharmacovigilance, which includes for example the establishment and support in the development of a quality system, execution of audits and supports in pre-arrangements for inspections. Apart of his nearly 20 years of experience in pharmacovigilance and his position of a QPPV, Christian is an expert in the field of regulatory affairs as well as pricing and reimbursement. Depending on the clients’ need, Christian is able to immerge to certain aspects of the manufacturing process and has experience with medical devices and food supplements.

Pharmacovigilance, Food Supplements

Mag. Monika Kunrath

Monika is one of the four co-founders of ARAC. Monika has a master degree (Mag. rer. nat.) in zoology from the University of Vienna. With nearly 20 years of experience as Regulatory Affairs specialist, she has strong expertise in regulatory affairs, liaison with authorities and marketing authorization applications and other regulatory matters within the European Union. She perfectly coordinates the interface between clients (pharmaceutical companies), employees and authorities.

Regulatory Affairs

Dr. Günter Komarnicki, MSc.

Günter gained a PhD degree in biology and has also a master degree for environmental management. After several years as research assistant and lecturer at the Medical University of Vienna and after some time in extramural human genetics, he joined ARAC in 2010. Starting also with regulatory affairs and pricing and reimbursement, he developed his focus more and more on quality management and pharmacovigilance, thus becoming the quality manager and Deputy EU QPPV of ARAC. Today he has a profound expertise in pharmacovigilance and quality management and acts at ARAC as pharmacovigilance specialist and as a consultant for quality management for which he also has experience as an auditor. His work is characterized by customer orientation, flexibility and innovative ability.

Pharmacovigilance, QM Systems, Inspections, Licenses

Mag. Martina Schuster

Martina joined ARAC in 2008. She started her career in the pharmaceutical industry in 2007 at GlaxoSmithKline Pharma GmbH, Vienna in the area of Regulatory Affairs. Martina has a university degree in Microbiology and spent several years as a research fellow at the Medical University of Vienna and the Children’s Cancer Research Institute where she was involved in development of tumor vaccines. At ARAC Martina works as an expert in the field of Regulatory Affairs. She is ARAC’s expert regarding allergen applications. Furthermore, Martina is a member of the Pricing & Reimbursement-Team, where she mainly takes over generic reimbursement applications at the Austrian Federation of Social Insurance Institutions.

Market Access, Regulatory Affairs

Dr. Harald F. Sigmund, MSc.

Harald gained a master degree in biochemistry at the University of Vienna and a PhD in food and biotechnology at the University of Agricultural Sciences. After a Post-Doc at the University of Agricultural Sciences, he switched to pharmaceutical industry in varying positions in the fields of regulatory affairs, pharmacovigilance and quality, where he gained broad expertise. Harald joined ARAC in 2014, where he supports both regulatory affairs and pharmacovigilance in every respect. With his more than 10 years of experience in the industry and a particular focus on pharmacovigilance as well as the chemical and manufacturing part, his strict quality-orientation is highly valued by our customers.

Regulatory Affairs, Pharmacovigilance

Anna Rubik, MSc.

Anna gained her first experiences in Regulatory Affairs during an internship at CSC/Angelini group in Austria. After completing her studies she supported the TEVA-ratiopharm Arzneimittel-Vertriebs-GmbH Regulatory Affairs team for several months and she also made her first steps in the Pharmacovigilance area. In October 2012 she joined the team of ARAC and continued to work in Regulatory Affairs and Pharmacovigilance. Anna is mainly responsible for marketing authorization applications and the life cycle management within the EU, as well as agency electronic workflow and communication with authorities (electronic submission activities such as PSUR repository, eAF, CES(S)P, Eudralink, and national communication portals). Since July 2012 Anna holds a MSc in “Medical and Pharmaceutical Biotechnology”. Furthermore she is a member of MEGRA and DGRA.

Regulatory Affairs

Anna Maria Edermayr, BSc.

Anna joined ARAC in 2013 after completing a Bachelor’s degree in Medical and Pharmaceutical Biotechnology. She started working in the field Pricing and Reimbursement and extended her skills in the areas Regulatory Affairs and Pharmacovigilance. Her core competencies are the preparation and submission of reimbursement applications, the communication with the Authorities according to the lawful regulations and her firm knowledge about the Falsified Medicines Directive. Attending and completing many events and workshops Anna gained broad experience within the field of the identification of medicinal products, additionally, she provides notifications of cosmetic products over CPNP. Besides her job at ARAC AT she is currently aiming her Master’s degree in Biomedicines.

Market Access, Pharmacovigilance, Cosmetics

Dr. Eszter Kapusi, MSc.

Eszter earned her PhD degree at the Martin Luther University of Halle-Wittenberg, Germany in 2010, after obtaining her second Master of Science degree in environmental management from the University of San Francisco (USF). She moved to Vienna in 2011 to work as a postdoctoral researcher at the University of Natural Resources and Life Sciences (BOKU) in the field of plant biotechnology, genetics and genome engineering. She joined the ARAC team recently in summer 2019 and started working in the area of Pricing & Reimbursement, as well as pharmacovigilance. She supports the team with the preparation and submission of reimbursement applications, communication with the Austrian Social Security Institutions and pharmacovigilance activities.

Market Access, Pharmacovigilance