Outsourcing Platform on PUblishing & Submission Services “OPPUS”

BlueReg Group Enregistrement de médicaments OPPUS FR

Outsourcing Platform on PUblishing & Submission Services “OPPUS”

As an outsourcing and consulting services company, 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 (eCTD, 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 any pharmaceutical forms of drugs and biologicals

Project Management

  • Planning, managing, tracking and ensuring on-time Published Dossier to meet Submission timelines
  • Provide advice to optimize Efficiency and Quality
  • Submission Formats and Publishing Specification updates
  • Publishing and Formatting on-site Trainings

Zone Expertise

  • EUROPE – Centralised, Decentralised, Mutual Recognition, National Procedures, CTA & IMPD
  • USA – IND, NDA, aNDA, BLA, IDE and 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 other than eCTD and NeeS Formats
  • Expertise in submitting Baseline Dossiers, ICH E3 eCSR, ASMF and DMF
  • Submission Portals: EMA Gateway, CESP; FDA & Health Canada Gateway

Formatting

  • PDF ready for Submission
  • Word Formatting for eCTD Compliant Conversion

Outsourcing Platform help you to design the appropriate support you need

In all these activities, BlueReg will support you by:

 

  • Providing a dedicated team of BlueReg consultants highly experienced in Publishing and Submission activities
  • Ensuring 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 worldwide Publishing and Regulatory Submission requirements
  • Being involved at every stage of your projects:
    • Formatting your documentation according to electronic submission 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
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Publishing & Document Compliance Tools

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

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 study cases

  • Assign a Publishing Team
  • Plan the publishing steps and timelines through meeting(s) with the teams
  • Check and format the documentation
  • Publish in BlueReg or Client environment
  • Double QC and Validation according to Country/zone requirements
  • Transfer of the dossier + Validation
  • Reports
  • Submission (If requested by client)
  • Archiving (GED)
  • Lessons Learned Meeting

Document Compliance Tools & Expertise study cases

  • Assign a Document Compliance Team
  • Prepare the formatting step through meetings with client
  • Format your documentation according to Client/BlueReg requirements
  • Double QC
  • Transfer of the formatted documentation
  • Lessons Learned Meetings

Stratégie d’enregistrement

Préparation et rédaction de rapports d'études cliniques

Rédaction du dossier CTD

CMC Regulatory support