- Putting in place a robust regulatory intelligence managementProject process to ensure compliance with national regulatory requirements. Approval Regulatory - Building and maintaining flexible and strong working & support strategy & for launch coordination relationships. activities - Development of KPIs and processes for continual monitoring. Geographical - Proposing a quality assurance plan and maintaining a Responses to Roll Out of Preparation,writing & smooth transition between all steps of the project questions compilation of Registrations Core dossier At a regulatory level - Provision of strategic input on all steps of the registration process. - Meet regulatory guideline requirements or provide Publishing & Gap Analysisversus Core justification on the deviations present in your dossier. Submission dossier - I nteractions and meetings withthe Competent Collection of local Authorities. requirements with support of local affiliates & - Provision of operational support by coordinating the partners dossier preparations including: • Core dossier Outsourcing Platform - Support in writing updated/compiled CMC, nonclinicaland clinical CTD core dossier documents on Registration - Design geographic roll-out plan to align with market launch strategy for Export Countries • Geographical Roll-Out - tailored dossiers as per local requirements: - Gap analysis of the core dossier vs national “OPREC” requirements and preparation of any additional required documents - Preparation of the administrative documents as In all these activities, BlueReg will provide you per local requirements including coordination of with tailored consulting services legalisation, translations & samples - Preparation, submission and follow up of active At a project management level substance and/or manufacturing site registration - Providing a dedicated BlueReg team highly experienced dossiers when required in project management, regulatory affairs, writing and - Compiling registration dossiers, publishing & publishing activities. submission to Authorities according to local - Oversight of a project manager to ensure consistency requirements and the highest quality. - Coordination, preparation and submission of responses - Sharing with your company the BlueReg best practice to questions guide and integration kit to make sure that all team - Follow-up until local approvals members have access to the same level of information. - Support for local launch activities BlueReg Specialists BlueReg has a dedicated team of experts in project management, Regulatory Affairs, writing and publishing providing flexible solutions to support your needs on a daily basis. No matter how complex your requirements are, BlueReg experts can help you to design the appropriate support you need.