Outsourcing Platform on Publishing & Submission Services “OPPUS”

BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide. BlueReg provides a broad range of services for electronic Submissions (eSubmissions). These include publishing expertise (electronic Common Technical Documents (eCTD), non-eCTD electronic Submissions (NeeS) and paper formats), document compliance, gateway submission and project management supported by the expertise of our consultants and our international qualified partners. We provide flexible operational platforms to meet your company’s needs for all pharmaceutical forms of drugs and biologicals

Project Management

  • Planning, managing, tracking and ensuring on-time published dossiers to meet submission timelines
  • Provide advice to optimise efficiency and quality
  • Submission formatting and publishing specification updates
  • Publishing and formatting on-site training

Zone and Agency Expertise

  • EUROPE – Centralised, Decentralised, Mutual Recognition, National Procedures, Clinical Trial Application (CTA) and Investigational Medicinal Product Dossier (IMPD)
  • US – Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (aNDA), Biologics License Application (BLA), Investigational Device Exemption (IDE) and Pre-Market Approval (PMA)
  • Swiss Medic
  • NDS Health Canada
  • Australia
  • ASEAN, GCC and Rest of the World

eSubmission Expertise

  • eCTD / NeeS strategy and submission expertise throughout the world
  • Expertise in submission types in addition to eCTD and NeeS formats
  • Expertise in submitting baseline dossiers, ICH E3 eCSR, Active Substance Master File (ASMF) and Drug Master File (DMF)
  • Submission Portals: European Medicines Agency (EMA) Gateway, Common European Submission Portal (CESP); Food and Drug Administration (FDA) and Health Canada Gateway

Formatting

  • PDF ready for submission
  • Word formatting for eCTD compliant conversion

 

Outsourcing platform to help design the appropriate support needed at every step of your product lifecycle.

In all these activities,
BlueReg will:

  • Provide a dedicated team of BlueReg consultants, highly experienced in publishing and submission activities
  • Ensure project management oversight to maintain consistency and high quality
  • Put in place a robust regulatory intelligence process to ensure compliance with worldwide publishing and regulatory submission requirements
  • Be involved at every stage of your projects:
    • Formatting your documentation according to electronic submission requirements
    • Ensuring publishing according to local needs
  • Develop processes and Key Performance Indicators (KPIs) for continuous monitoring
  • Propose a quality assurance plan and maintain adequate transition between all project steps
  • Publishing and Document Compliance Tools

 

No matter how complex your requirements are, BlueReg experts can help you to design the appropriate support needed.

Publishing Tools & Expertise

  • Publishing Tools
    • Extedo eCTD Manager
    • Insight Publisher
  • Validators
    • Lorenz Validator
    • EURS Validator
    • Insight Validator

Document Compliance Tools & Expertise

  • Adobe Acrobat DC
  • MS Word
  • ISIToolbox
  • PitStop Pro
  • Quite Revealing
  • Evermap
  • Mapsoft

Publishing Project Case Study

  • Assign a publishing team
  • Plan the publishing steps and timelines through client / team meetings
  • Check and format the documentation
  • Publish in BlueReg or client environment
  • Double QC and validation according to country/zone requirements
  • Transfer of the dossier and validation reports
  • Submission (if requested by client)
  • Archiving in the document management system (DMS)
  • Lessons learned meeting

Document Compliance Tools & Expertise Study Cases

  • Assign a document compliance team
  • Prepare formatting step through meetings with client
  • Format of documentation according to client/Health Authorities requirements
  • Double QC
  • Transfer of the formatted documentation
  • Lessons learned meetings

Our experts

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