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:
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.
- Briefing Packages, Clinical Trial Applications (CTA),
- Investigational New Drug Applications (IND),
- Investigational Device Exemptions (IDE).
- 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.
- Amendments, Baselines, Renewals, Variations, PSURs
- 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).
- EUROPE – Centralised, Decentralised, Mutual Recognition, National Procedures
- ASEAN, GCC and Rest of the World
Tools & Expertise
- Extedo eCTD Manager
- Liquent Insight Publisher
- 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
We can submit any of your electronic dossiers through the relevant submission portals:
- EMA Gateway
- FDA Gateway
- MHRA Portal
- PSUR Repository
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.
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
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.
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.
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.
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.
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
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.
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.
BlueReg can support with routine pharmacovigilance activities for early access programs, clinical trials or post-marketing
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.
Scientific & 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.
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.
Specific Services for Europe
BlueReg has a dedicated team who cover the whole development process from concept to approval, on centralized or multi-national projects. Our consultants have diverse experience ranging from regulatory strategy to operational execution and full project management support will be provided.
Publishing and Submission of a grouped application of Type IAIN Variations (IA-Supergroup)
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Publishing & Submission of eCTD baselines through the national procedure in Europe
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