Bluereg / Post AMM
For example, our team can assist you with :
BlueReg supports various companies with their post-approval activities: like pharmaceutical companies who want to outsource post-approval activities to focus their internal resource on development projects or those who do not have the regulatory expertise or a local representative in the EU or rest of the world.
BlueReg provides strategic advice and operational support, representation of the regulatory function on project teams and submission of any post-authorisation activities.
BlueReg uses in-house resources from our team and our international qualified partners. One single point of contact would be allocated for each project. All our consultants have significant industry experience in lifecycle management and liaising with the regulatory agencies (EU and RoW).
In all these activities, BlueReg will support you in:
– Providing a dedicated team of BlueReg consultants highly experienced in post-authorisation activities
– Ensuring a project management oversight to maintain consistency and high quality
– Sharing with your company the BlueReg best practice guide and integration kit to make sure that all team members have access to the same level of information
– Putting in place a robust regulatory intelligence process to ensure compliance with the national regulatory requirements
– Being involved at every stage of your projects:
– Developing processes and KPIs for continuous monitoring
– Proposing a quality assurance plan and maintaining adequate transition between all steps of the projects
BlueReg has dedicated regulatory consultants, highly experienced in all post-authorisation activities, 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
Safety and / or CMC compliance project
– Assign a dedicated compliance team
– Launch a geographical roll out of corresponding variations /notifications (preparation & submission)
– Follow up until local implementation