Scientific Advice and Dialogue with EMA during Drug Development

Scientific Advice and Dialogue with EMA during Drug Development

Whitepapers

During drug development pharmaceutical companies need to establish their regulatory strategy and define timelines for their clinical studies. To support small and medium-sized enterprises (SME, <250 employees and 50 million euros annual turnover), the European Medicines Agency (EMA) created the SME Office in 2005. This dedicated platform provides regulatory, financial and administrative assistance to SME. The overview of the incentives is available on the EMA website. In 2017, more than 1800 pharmaceutical companies were registered to the SME Office, confirming the success of this initiative.

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