Post AMM

Our team can help you to meet your goals in all types of post-authorisation activities for your medicinal products, drugs and biologics, registered worldwide.

For example, our team can assist you with :

 

  • All stages of variations (administrative, safety, CMC etc.), renewal, license transfers, management of post-approval commitments
  • Advice on variation classification and local requirements such as European grouping / super grouping and work-sharing procedures
  • CMC and safety compliance: gap analysis between approved pharmaceutical parts or clinical parts and reference documents and to set-up the appropriate strategy to upgrade the corresponding part of the file
  • Advice on line extension, legal switch application, inform consent file, …
  • Support for referral
  • Support for the process of linguistic review and other translations
  • Support with local launch preparation

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).

OPPARS
Outsourcing Platform on Post-Authorisation Regulatory Services

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:

  • Writing administrative, CMC, nonclinical and clinical CTD documents
  • Compiling CTD dossiers as per local requirements
  • Ensuring publishing according to local needs

– Developing processes and KPIs for continuous monitoring
– Proposing a quality assurance plan and maintaining adequate transition between all steps of the projects

BlueReg experts

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
you need.

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Safety and / or CMC compliance project

 

– Assign a dedicated compliance team
– Safety:

  • Review your reference documents such as CDS, CCDS, SmPC/USPI versus the current guidelines
  • Upgrade your reference documents accordingly and set up gap analysis versus your local SmPC/USPI
  • Develop regulatory strategy to locally implement reference texts in your local SmPC/USPI

– CMC:

  • Review all registered CMC dossiers versus technical reports issued from your manufacturing sites
  • Develop appropriate strategy to upgrade CMC dossiers
  • Prepare & submit the corresponding updated module 3 sections and QOS as per local regulations

– Launch a geographical roll out of corresponding variations /notifications (preparation & submission)
– Follow up until local implementation

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