Post Authorisation

Post Authorisation

Our team can help you to get the most out of your product following MAA approval and ensure that it is efficiently maintained and remains in compliance.
For example, our team can assist you in:

  • Advice on variation classification and data requirements
  • Guidance on grouping and work-sharing procedures
  • Preparation and assistance of variations, renewal applications, license transfers, legal switch applications
  • Management of post approval commitments
  • CMC compliance: gap analysis of pharmaceutical parts and remediation

BlueReg supports various companies with their post-approval activities; pharma companies who want to outsource post-approval activities to focus their internal resource on development projects; those who do not have an EU regulatory expertise or a representative in the EU.

BlueReg provides strategic advice and operational support, representation of the regulatory function on project teams and submission of any post-authorisation application.

We use in-house resource from within the BlueReg team and a single point of contact would be allocated for each project.  All our consultants have significant industry experience in lifecycle management and with liaising with the EU regulatory agencies.  They are also all passionate about lifecycle management and maintaining regulatory compliance.

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