"Based on the excellent knowledge of the Austrian market and the practical experience for years of our highly skilled specialists we can offer you a tailor-made support in the framework of all agenda concerning regulatory affairs."


arac-at-regulatory-affairs-pharmaceutical-consulting-strategic-advice-market-access-pharmacovigilance-food-suplements-cosmetics-due-dilligence-austria-qm-systems-inspections-licences-wien-vienna

ARAC. Benefit from the many years of experience, the high level of expertise and our very individual support.

arac-at-regulatory-affairs-pharmaceutical-consulting-strategic-advice-market-access-pharmacovigilance-food-suplements-cosmetics-due-dilligence-austria-qm-systems-inspections-licences-wien-vienna

ARAC. Benefit from the many years of experience, the high level of expertise and our very individual support.


REGULATORY AFFAIRS

Evaluating the best regulatory strategy and taking the products successful through the marketing authorization is our objective. Our regulatory team is experienced in all marketing authorization applications such as national procedures, MRPs, DCPs, CPs. They give strategic advice, compile dossiers in eCTD, manage the life cycle of products and are the interface to the pharmacovigilance and market access team. Read more


 
 

MARKET ACCESS

Market access should already start during the marketing authorization process by an early understanding of the needs of patients, the pricing policy in different markets and the requirements of payers. Consequently, our clients’ needs are evaluated as early as possible and integrated into development plans for optimal regulatory approval and market access.
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PHARMACOVIGILANCE

Pharmacovigilance has developed rapidly in the last years and become one of the major areas in the medical departments of the pharmaceutical industry. It is an essential task to recognize adverse events as early as possible and to guarantee the safety of patients when administering medicinal products.
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Our office is located in the heart of Vienna in the immediate vicinity of the world famous St. Stephen’s Cathedral and is easily accessible. We are looking forward to see you.