Outsourcing Platform on Registration for Export Countries “OPREC”

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 (International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use) and non-ICH regions by providing 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 has a dedicated team of experts in project management, regulatory affairs, writing and publishing providing flexible solutions to support your needs. No matter how complex your requirements are, BlueReg experts can provide full support.

At a project management level

  • Providing a dedicated BlueReg team highly experienced in project management, regulatory affairs, writing and publishing activities.
  • Oversight by a project manager to ensure consistency and the highest quality deliverables.
  • Sharing the BlueReg best practice guide and integration kit to ensure 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 Key Performance Indicators (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 in all stages of the registration process
  • Interactions and meetings with the Competent Authorities
  • Provision of operational support by coordinating the dossier preparation including:
  • Support in writing and/or updating Chemistry Manufacturing and Controls (CMC), nonclinical and clinical core dossier documents
  • Design geographic roll-out plan to align with market launch strategy:
  • Gap analysis of the core dossier against national requirements and preparation of any additional required documents
  • Preparation of the administrative documents as per local requirements including coordination of legalisation, translations and samples
  • Preparation, submission and follow up of active substance and/or manufacturing site registration dossiers when required
  • Compiling tailored registration dossiers, publishing and submission to Competent Authorities according to local requirements
  • Coordination, preparation and submission of responses to questions
  • Follow-up until local approvals are granted
  • Support for local launch activities

Our experts

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