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.
- 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
- ASEAN, GCC and Rest of the World
- 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
- 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
- Lorenz Validator
- EURS Validator
- Insight Validator
Document Compliance Tools & Expertise
- Adobe Acrobat DC
- MS Word
- PitStop Pro
- Quite Revealing
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
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
Clients rely on BlueReg’s regulatory intelligence as well as the experience and expertise of our consultants and partner network for the success of their projects. BlueReg can provide an end-to-end project plan to guide you through the regulatory preparation of the commercial product launch.
Advertising & Promotional Material Review
BlueReg is the strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance.
Life Cycle Management
The dedicated BlueReg lifecycle management product supply team are experts in navigating post approval activities and supporting client partners to successfully manage all post approval activities.
Looking for support in marketing your product in France? PharmaBlue, a BlueReg company, is a partner “Exploitant” of pharmaceutical companies for the marketing in France of their medicinal products which have been granted a temporary use authorization (ATU) or a marketing authorisation (MA).
Searching to Outsource Post Authorisation activities?
BlueReg can help with all post-authorization activities for your medicinal products worldwide.
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
BlueReg is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance.
Preparation, writing and redaction of clinical study reports
BlueReg can support you with a highly experienced team of professsionals in preparing and writing of your clinical study reports, supporting the redaction proposal and document package for submission to the EMA to comply with EMA policy 0070.
BlueReg will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services.
Bluereg has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product.
Publishing & submissions
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). You can rely on the BlueReg experienced team and efficient use of publishing and formatting tools to prepare your dossiers/documents according to Health Authority requirements.
Quality System and Audit
BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.
Pricing and reimbursement (Drugs and Medical devices)
BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).
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