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
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
Clients rely on BlueReg’s regulatory intelligence as well as the experience and expertise of our consultants and partner network for the success of their projects. BlueReg can provide an end-to-end project plan to guide you through the regulatory preparation of the commercial product launch.
Advertising & Promotional Material Review
BlueReg is the strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance.
Life Cycle Management
The dedicated BlueReg lifecycle management product supply team are experts in navigating post approval activities and supporting client partners to successfully manage all post approval activities.
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).
Searching to Outsource Post Authorisation activities?
BlueReg can help with all post-authorization activities for your medicinal products worldwide.
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
BlueReg is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance.
Preparation, writing and redaction of clinical study reports
BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.
BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
Bluereg has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product.
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.
Quality System and Audit
BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.
Pricing and reimbursement (Drugs and Medical devices)
BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).
BlueReg continues to expand in the US opening its second North American office in Boston.
Cambridge, Massachusetts, USA, December 13 2019, BlueReg, the consulting organization for life sciences companies, is...
News - 13 January 2020
Paul Kuiken : General Manager UK and Vice President Global Geographic Expansion
BlueReg Group is pleased to announce that Paul Kuiken has joined the company today as...
News - 23 May 2019