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.
Looking for peace of mind with outsourcing your regulatory projects and/or activities? BlueReg provides a tailored service with a continual monitoring and partnering with our experienced project managers to ensure a high quality of deliverables as per KPIs and metrics agreed at project initiation.
Drug Registration and Regulatory Roadmap
BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in other worldwide countries. Our team of experts can also facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.
BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in export countries.
Publishing & Submissions
BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. BlueReg provides a broad range of services for electronic Submissions (eSubmissions). You can rely on the BlueReg experienced team and efficient use of publishing and formatting tools to prepare your dossiers/documents according to Health Authority requirements.
Looking for support of small to medium enterprise (SME) status in the European Union? BlueReg coordinates SME client status dossier preparation and submission through its experienced project management team. BlueReg can also optimise the application content to expedite the approval by EMA.
BlueReg is your strategic partner to meet your goals for all medicinal product registrations worldwide. BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world
Early Access Programmes (ATU)
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs (ATU) projects (nominative and cohort) in France .
Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).