BlueReg Group Outsourcing Programs Program Management Program Management BlueReg has developed a unique methodology to support your projects when complete or partial outsourcing is required along with appropriate project management tools. That can concern: European & US registrations Worldwide geographical rollout Lifecycle management, launch, and Early access programs Promotional material review Publishing The Project manager A tailored service with a continual monitoring will be set up by the Project manager to ensure a high quality of deliverables and respect of timelines as per KPIs and metrics agreed at the project initiation. Long relationship is key for such a project and BlueReg focus will be to maintain smooth transition between all steps of the project and ensure that roles & responsibilities are clear for all stakeholders (RACI). “For any of these activities, a BlueReg Project Manager will be assigned to your project as key contact point person along with a dedicated team of highly experience BlueReg consultants specialised in regulatory affairs, scientific writing or publishing.” Our experts Our team can also support you through the entire application process from development, to registration and post-approval management Claire Ray Nadia Boehringer Associated News FDA GUIDANCE – COVID-19 BlueReg continues to monitor the changes in the regulatory guidance and we wish to share... Learn more EMA GUIDANCE – COVID-19 Given the support given to our clients in interactions with health authorities all around the... Learn more eCTD Format Mandatory for EU National Procedures After CP, DCP/MRP Procedures, and according to the eSubmissions Roadmap Timelines, eCTD format is now... 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