Strategy on classification, regulatory plan Geographical roll out Linguistic review process Safety & CMC compliance project: CCDS/ Ensure local regulatory Advice on proposed regulatory reference document, gap analysis requirements are met Perform the review of PQR actions if needed Follow up until local implementation Audit to prepare for inspection on behalf of the MAH Product Referral Quality Review Interactions Line Support Regulatory Act as PM with Health extensions GMP intelligence Follow KPIs Authority inspection and Metrics Communication with all the team involved File Variations / Support Product Project Translation Notifications PV management Lifecycle inspection Support Regulatory review PSUSA / PBRER Blue box of promotional Preparation and Serialisation materials for submission Pharmaco- Post-approval Launch Global international commitment Packaging promotional congress or “basket PSMF support vigilance management Promotional review activities review of tools” / global Brand product launch optimisation Renewals & lifecycle management Outsourcing Platform on BlueReg experts BlueReg has dedicated regulatory consultants, highly Post-Authorisation Regulatoryexperienced in all post-authorisation activities, providing flexible solutions to support your needs on a daily basis. Services “OPPARS” No matter how complex your requirements are, BlueReg experts can help you to design the appropriate support you need. In all these activities, BlueReg will support you in: - Providing a dedicated team of BlueReg consultants highly experienced Safety and / or CMC compliance project in post-authorisation activities - Assign a dedicated compliance team - Ensuring a project management oversight to maintain consistency - Safety: and high quality • Review your reference documents such as CDS, CCDS, - Sharing with your company the BlueReg best practice guide and SmPC/USPI versus the current guidelines integration kit to make sure that all team members have access to • Upgrade your reference documents accordingly and set up the same level of information gap analysis versus your local SmPC/USPI • Develop regulatory strategy to locally implement reference - Putting in place a robust regulatory intelligence process to ensure texts in your local SmPC/USPI compliance with the national regulatory requirements - CMC: - Being involved at every stage of your projects: • Review all registered CMC dossiers versus technical reports • Writing administrative, CMC, nonclinical and clinical CTD documents issued from your manufacturing sites • Compiling CTD dossiers as per local requirements • Develop approriate strategy to upgrade CMC dossiersp • Ensuring publishing according to local needs • Prepare & submit the corresponding updated module 3 sections - Developing processes and KPIs for continuous monitoring and QOS as per local regulations - Proposing a quality assurance plan and maintaining adequate transition- Launch a geographical roll out of corresponding variations / between all steps of the projects notifications (preparation & submission) - Follow up until local implementation