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