BlueReg Group Commercialisation Export Countries 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 Our experts Our team can also support you through the entire application process from development, to registration and post-approval management Anne-Valérie Faucher Claire Ray Previous 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. Next Associated News 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... Learn more 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... Learn more Corinne Schmitz – Women for Future – Pharmaceutical Industry Expert This week, “La Tribune” and its partner Bpifrance have decided to present Corinne Schmitz, CEO... Learn more Contact our experts today Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management Make an enquiry About us Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success. Our links Affiliations Careers Terms of use Privacy Policy GDPR Get in touch with us here: contact@blue-reg.com Manage Cookies This site uses cookies and gives you control over what you want to activate OK, accept all Deny all cookies Personalize