The small and medium sized enterprise (SME) program is a new initiative by the EMEA (European Agency for the Evaluation of Medicinal Products) dedicated to addressing the particular needs of small and medium size companies developing medicinal products in Europe.
Companies granted SME status are able to seek assistance, information and training from dedicated EMEA personnel, particularly regarding marketing authorization applications. In addition, SME status may accord companies reduced or deferred fees associated with marketing authorization applications, scientific advice and inspections.
SME status has been granted to Dor despite the company being based in the US because the company is represented in Europe by Voisin Consulting, a regulatory consulting SME firm with headquarters in France.
“We are very pleased to be one of the first US companies to benefit from the incentives granted by the SME initiative in Europe,” commented Michael Sember, president and CEO of Dor. “SME status represents important economic incentives for a small company such as Dor.”