Small and Medium-Sized Enterprises

Small and Medium Sized Enterprises (SMEs) are defined by the European Commission as enterprises with less than 250 employees and an annual turnover of up to 50 million EUR, or a balance sheet total of no more than 43 million EUR.

The SME designation promotes innovation and the development of new Drugs by providing administrative, regulatory and financial support from the European Medicines Agency (EMA), including:

  • Fee exemptions and reductions for pre- and post-authorization regulatory procedures, including scientific advice, inspections and pharmacovigilance.
  • Assistance with the translation of product information into all official
  • European Union (EU) languages.
  • Workshops and training sessions.
  • Liaison with academic investigators in pediatric medicine research.

How can DDR help?

  • DDR has officially been designated as an SME and, therefore, is allowed to act as EU SME representative on behalf of companies fulfilling SME criteria and based outside the EU.
  • DDR will prepare, review and submit the SME designation application form and related documentation.
  • DDR will handle interactions with the EMA.
  • DDR will be responsible for the annual SME designation renewal.

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