BlueReg Group Registration Publishing & Submissions Publishing & Submission Services BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. The flexibility of our operational platform will meet your company’s needs for any pharmaceutical forms of drugs and biologicals. Supported by the expertise of our consultants and our international qualified partners, BlueReg provides a broad range of services, including: Publishing Document Compliance / Formatting Electronic Submission Publishing Our highly qualified experts perform eCTD, NeeS or paper publishing for any registration procedure worldwide. These cover drug development, initial applications and post-approval activities (existing eCTD lifecycle sequences can be imported into our system). We provide tailored solutions to publish dossiers in the BlueReg or client environment and ensure their technical validation according to the latest validation criteria. Publishing Expertise Zone/Country Expertise Tools & Expertise Document Compliance / Formatting Making documents eCTD-ready, can be a very time-consuming task. BlueReg supports you to ensure your documents are compliant with ICH specifications and pass technical validation. We offer the following services: Formatting MS Word files Processing PDF documents (e.g. PDF settings, bookmarking, hyperlinking etc.) Rendition from MS Word to PDF Electronic Submission We can submit any of your electronic dossiers through the relevant submission portals: CESP EMA Gateway FDA Gateway MHRA Portal PSUR Repository For all these activities, BlueReg will: Provide a dedicated team of BlueReg consultants, who are highly experienced in publishing, document compliance and submission activities Support you with project management in order to maintain consistency, high quality and ensure timely delivery of your dossiers Put in place a robust regulatory intelligence process to ensure compliance with worldwide publishing and regulatory submission requirements Provide publishing and formatting on-site training (on demand) No matter how complex your requirements are, BlueReg experts can help you to plan the support you need. Our experts Our team can assist you through the entire application process from development, to registration and post-approval management Franck Vigliecca Helen Hackett Simone Busson Previous Associated services Worldwide BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements Next Associated Resources Publishing and Submission of a grouped application of Type IAIN Variations (IA-Supergroup) A global specialty-driven biopharmaceutical group focused on innovation and specialty care entrusted BlueReg to co-ordinate... Learn more Publishing & Submission of eCTD baselines through the national procedure in Europe A global specialty-driven biopharmaceutical group focused on innovation and specialty care, entrusted to BlueReg the... Learn more Publishing – Marketing Campaign in US, EU, CA & CH A global pharmaceutical company specialising exclusively in the research, development and marketing of medical solutions... 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