Outsourcing Platform on Registration for Export Countries “OPREC”
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, supported by the expertise of our consultants and our international qualified partners.
BlueReg will support your geographic registration roll out in ICH (International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use) and non-ICH regions by providing advice and regulatory support on the various critical steps of your regulatory plans. We provide flexible operational platforms to meet your company’s needs for any pharmaceutical forms of drugs and biologicals.
BlueReg has a dedicated team of experts in project management, regulatory affairs, writing and publishing providing flexible solutions to support your needs. No matter how complex your requirements are, BlueReg experts can provide full support.
At a project management level
- Providing a dedicated BlueReg team highly experienced in project management, regulatory affairs, writing and publishing activities.
- Oversight by a project manager to ensure consistency and the highest quality deliverables.
- Sharing the BlueReg best practice guide and integration kit to ensure that all team members have access to the same level of information.
- Putting in place a robust regulatory intelligence process to ensure compliance with national regulatory requirements.
- Building and maintaining flexible and strong working relationships.
- Development of Key Performance Indicators (KPIs) and processes for continual monitoring
- Proposing a quality assurance plan and maintaining a smooth transition between all steps of the project
At a regulatory level
- Provision of strategic input in all stages of the registration process
- Interactions and meetings with the Competent Authorities
- Provision of operational support by coordinating the dossier preparation including:
- Support in writing and/or updating Chemistry Manufacturing and Controls (CMC), nonclinical and clinical core dossier documents
- Design geographic roll-out plan to align with market launch strategy:
- Gap analysis of the core dossier against national requirements and preparation of any additional required documents
- Preparation of the administrative documents as per local requirements including coordination of legalisation, translations and samples
- Preparation, submission and follow up of active substance and/or manufacturing site registration dossiers when required
- Compiling tailored registration dossiers, publishing and submission to Competent Authorities according to local requirements
- Coordination, preparation and submission of responses to questions
- Follow-up until local approvals are granted
- Support for local launch activities
Associated services
Program Management
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.
Associated services
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.
Associated services
Registration
BlueReg provide expertise in registration strategy in the US or in Europe, provide manpower to produce high quality registration dossiers using our multidisciplinary team of regulatory affairs, scientific writing, and publishing, and manage submission process through to a satisfactory conclusion
Associated services
SME representation
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.
Associated services
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.
Associated services
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
Associated services
Early & Expanded Access Programs in France
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 projects in France .
Associated services
Exploitant Services
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).
