SME Representation

BlueReg is registered as SME (Small and Medium-sized Enterprises) by the EMA and can support non European economic area (EEA) enterprise by accessing micro, small and medium sized enterprises (SMEs) incentives granted by the EMA through the BlueReg (BR) SME status, per the Commission Regulation (EC) 2049/2005 and EMA user guide for SMEs.

 

 

The SME criteria are based on the enterprise’s size e.g. number of employees, annual turnover and ownership structure. If SME companies are not established in the European Union (EU)/European Economic Area (EEA), SME incentives can be accessed through BlueReg regulatory consultancy who has the SME status. BlueReg and their EMA approved SME clients have access to several benefits such as administrative, regulatory and financial support (e.g. EMA fee reductions for scientific advice, inspections and post authorisation procedures; EMA fee deferral until outcome for a marketing authorisation application).

BlueReg coordinates SME client status dossier preparation and submission. BlueReg can also optimise the application content to expedite the approval by EMA. In terms of methodology, BlueReg will assign a project manager who will act as main contact point with the client and coordinates BlueReg consultants and related activities. The regulatory consultant(s) will provide the operational support by collecting the required documentation from the relevant stakeholders to put the client’s SME dossier together. Submission and maintenance of the SME dossier is under his/her responsibility. The consultant will act as main contact point for the EMA/SME office on the client’s behalf.