Empowering Innovation: EMA Support for SMEs Through Scientific Advice and Early Dialogue

Empowering Innovation: EMA Support for SMEs Through Scientific Advice and Early Dialogue

In this Ardena Insight, we highlight how the European Medicines Agency (EMA) empowers small and medium-sized enterprises (SMEs) through scientific advice and early regulatory dialogue. These initiatives help SMEs define their development strategy and streamline clinical timelines during drug development.

Since the creation of the EMA SME Office in 2005, pharmaceutical companies with fewer than 250 employees and annual turnover below €50 million have gained access to tailored regulatory, financial and administrative support. By 2017, over 1,800 companies had registered, demonstrating the growing impact of this dedicated platform.

At Ardena, we guide emerging biotechs through regulatory pathways, helping you make the most of EMA incentives and accelerate your innovation.

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