BlueReg Group Commercialisation Launch Activities Launch Activities BlueReg is well known for supporting companies through product registration and the launch phase. Not only are there specific steps required to turn the regulatory filing to a tangible product for supply and distribution but also this is happening usually when the client is transitioning from Research and Development to a commercial organisation. There can be several activities running in parallel during the launch phase including label management, dossier updates, urgent post approval variations or registrations being filed in other markets and pricing and reimbursement. To coordinate this array of activity requires experience, organisation, and credible support. Our consultants have walked in your shoes and have completed this activity on countless occasions either in the pharmaceutical companies themselves or now in supporting our clients. To support launch activity there must be a robust and comprehensive launch plan, involvement of stakeholders and the manpower to support the varying tasks. BlueReg have templates to help with this, best practice from years of support, and inherent expertise. We are constantly referred by clients to their peers in the industry. Time to engage with BlueReg BlueReg is the strategic partner to meet client goals for launch activity for drugs and medical devices. We provide a broad range of services linked to the review of launch activities and these flexible solutions range from an integrated package of services to adapted ad-hoc regulatory and technical support. Our goal is to explore innovative approaches and provide relevant advice to ensure clients maintain competitiveness in this complex and changing regulatory environment. We manage activity according to local market requirements anywhere in the world. Support and services Clients rely on our regulatory intelligence as well as the experience and expertise of our consultants for the success of their project. BlueReg can provide you with an end-to-end project plan to guide you from registration strategy through to authorisation and beyond. Services we offer include: Provide local regulatory requirements for launch Assess the packaging transition from Early Access Program (EAP) to a full commercial launch if required, providing full local market requirements Support / provide regulatory input on the launch sequence Optimise the market launch rollout in terms of shared packs considering the full constraints such as language, serialisation, local pictogram and local code Manage and plan artwork changes carefully within the lifecycle activities Support the artwork packaging team / supply chain to deliver the product on time to patients with timely responses to ad hoc requests Support the regulatory review of local promotional materials for launch Support any local regulatory request/submission (including local number, local sequence, local database etc) Associated services Promotional Material Review 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. 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