As an outsourcing and consulting services company, BlueReg is your strategic partner to meet your goals for all medicinal product registrations worldwide. BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world, supported by the expertise of our consultants and our international qualified partners.

BlueReg will support your geographic registration roll out in ICH and non-ICH regions by providing you with advice and regulatory support on the various critical steps of your regulatory plans. We provide flexible operational platforms to meet your company’s needs for any pharmaceutical forms of drugs and biologicals.

BlueReg Specialists

BlueReg has a dedicated team of experts in project management, Regulatory Affairs, writing and publishing 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.

At a project management level

  • Providing a dedicated BlueReg team highly experienced in project management, regulatory affairs, writing and publishing activities.
  • Oversight of a project manager to ensure consistency and the highest 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 national regulatory requirements.
  • Building and maintaining flexible and strong working relationships.
  • Development of KPIs and processes for continual monitoring.
  • Proposing a quality assurance plan and maintaining a smooth transition between all steps of the project

At a regulatory level

  • Provision of strategic input on all steps of the registration process.
  • Meet regulatory guideline requirements or provide justification on the deviations present in your dossier.
  • Interactions and meetings with the Competent Authorities.
  • Provision of operational support by coordinating the dossier preparations including:
  • Core dossier
    – Support in writing updated/compiled CMC, nonclinical and clinical CTD core dossier documents
    – Design geographic roll-out plan to align with market launch strategy
  • Geographical Roll-Out – tailored dossiers as per local requirements:
    – Gap analysis of the core dossier vs national requirements and preparation of any additional required documents
    – Preparation of the administrative documents as per local requirements including coordination of legalisation, translations & samples
    – Preparation, submission and follow up of active substance and/or manufacturing site registration dossiers when required
    – Compiling registration dossiers, publishing & submission to Authorities according to local requirements
    – Coordination, preparation and submission of responses to questions
    – Follow-up until local approvals
    – Support for local launch activities