Post Authorisation

BlueReg Group is your strategic partner to meet your goals in all types of post-authorisation activities for your medicinal products.

BlueReg Group provides comprehensive local regulatory affairs services across the world, supported by the expertise of our consultants and our international qualified partners. We provide flexible operational platforms to meet your company’s needs for any pharmaceutical forms of Drugs & Biologicals.

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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