Publishing & Submission Services

BlueReg is your strategic partner to meet your goals in publishing activities and regulatory submissions worldwide.

 

The flexibility of our operational platform will meet your company’s needs for any pharmaceutical forms of drugs and biologicals.

 

Supported by the expertise of our consultants and our international qualified partners, BlueReg provides a broad range of services, including:

 

Publishing

Our highly qualified experts perform eCTD, NeeS or paper publishing for any registration procedure worldwide. These cover drug development, initial applications and post-approval activities (existing eCTD lifecycle sequences can be imported into our system).

 

We provide tailored solutions to publish dossiers in the BlueReg or client environment and ensure their technical validation according to the latest validation criteria.

PUBLISHING BlueReg

Publishing Expertise

Pre-MAA:

  • Briefing Packages, Clinical Trial Applications (CTA),
  • Investigational New Drug Applications (IND),
  • Investigational Device Exemptions (IDE).

 

MAA (Worldwide):

  • Marketing Authorisation Applications (MAA),
  • New Drug Applications (NDA),
  • Biologics License Applications (BLA),
  • Abbreviated New Drug Applications (ANDA),
  • Pre-Market Approval (PMA), New Drug Submissions (NDS) etc.

 

Post-MAA:

  • Amendments, Baselines, Renewals, Variations, PSURs

 

Other:

  • Clinical Study Reports (ICH E3 eCSR),
  • Active Substance Master Files (ASMF),
  • Drug Master Files (DMF),
  • Pharmacovigilance System Master Files (PSMF),
  • Investigational Medicinal Product Dossiers (IMPD).

 

Zone/Country Expertise

  • EUROPE – Centralised, Decentralised, Mutual Recognition, National Procedures
  • Switzerland
  • USA
  • Canada
  • Australia
  • ASEAN, GCC and Rest of the World

Tools & Expertise

Publishing Tools

  • Extedo eCTD Manager
  • Liquent Insight Publisher

 

Validators

  • Lorenz Validator
  • EURS Validator
  • Insight Validator

Document Compliance / Formatting

Making documents eCTD-ready, can be a very time-consuming task.

BlueReg supports you to ensure your documents are compliant with ICH specifications and pass technical validation.

 

We offer the following services:

 

  • Formatting MS Word files
  • Processing PDF documents (e.g. PDF settings, bookmarking, hyperlinking etc.)
  • Rendition from MS Word to PDF
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Electronic Submission

We can submit any of your electronic dossiers through the relevant submission portals:

 

  • CESP
  • EMA Gateway
  • FDA Gateway 
  • MHRA Portal
  • PSUR Repository

 

Human behavior Human

For all these activities, BlueReg will:

  • Provide a dedicated team of BlueReg consultants, who are highly experienced in publishing, document compliance and submission activities

 

  • Support you with project management in order to maintain consistency, high quality and ensure timely delivery of your dossiers

  • Put in place a robust regulatory intelligence process to ensure compliance with worldwide publishing and regulatory submission requirements

 

  • Provide publishing and formatting on-site training (on demand)

No matter how complex your requirements are,

BlueReg experts can help you to plan the support you need.

 

Associated services

Worldwide

BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements

Associated services

Product Registration in the US & EU

Do you want to register your healthcare product in the United States or the European Union? BlueReg has a team whose expertise covers the entire development process, from concept to marketing authorization, on centralized and / or multinational projects. Our consultants have varied experience ranging from regulatory strategy to operational execution.

Associated services

International Registration

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.

 

Associated services

United States

Looking for help with regulatory activities in the United States?  BlueReg can help to navigate the Food and Drug Administration (FDA) regulations and provide support and advice for all your project requirements.

Associated services

Drug Registration and Regulatory Roadmap

BlueReg can be your preferred partner to support the registration of your medicinal product in Europe, in the US or in other worldwide countries. Our team of experts can also facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.

Associated services

Export Countries

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

Associated services

CTD Dossier Writing

BlueReg can collaborate with your experts to author, review and update your Common Technical Document (CTD) as required for new Marketing Authorisation Application (MAA) submissions or during the lifecycle of the medicinal product.

Associated services

Pharmacovigilance

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.

Associated services

Safety reports

Bluereg has extensive experience in writing safety documents and can support you with assessing a product’s risk benefit profile for your product. 

Associated services

Pharmacovigilance

BlueReg can support with routine pharmacovigilance activities for early access programs, clinical trials or post-marketing

Associated services

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. 

Associated services

Scientific and CTD Dossier Writing

BlueReg provide flexible solutions for scientific writing covering all kinds of engagements or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.  Our team are experienced in writing clinical modules for submission in the EU and the US, PIPs, ODDs, INDs, IMPDs and IBs, as well as briefing packages for scientific advice.  The team also manage Chemistry Manufacturing and Controls (CMC) writing for chemical and biological products.

Associated services

CMC Regulatory support

Our CMC Regulatory support services include everything from regulatory strategy and preparation of meetings with health authorities, assessment and preparation of regulatory documents, responses to agency questions, maintenance of products on market, regulatory compliance strategy worldwide and geographical roll out.

Associated services

Regulatory Affairs Consulting EU

Our team composed of global experts from the pharmaceutical industry provides the necessary support to help you succeed in all regulatory aspects of life sciences in Europe from development, registration through to commercialization.

Associated services

Specific Services for the United States

BlueReg consultants can help navigate FDA regulations and provide support and advice for all your project requirements

Case study

Publishing and Submission of a grouped application of Type IAIN Variations (IA-Supergroup)

A global specialty-driven biopharmaceutical group focused on innovation and specialty care entrusted BlueReg to co-ordinate the publishing and submission of...

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