Registration & Early Access

With clinical trials nearing an end, non-clinical study reports finalised, the Quality and Chemistry and Manufacturing Controls (CMC) dossier nearing finalisation, planning and executing the new registration application is critical for the timely success of the product development programme.

 

Clients need the help of BlueReg to provide the expertise in registration strategy in the US or in Europe, to provide the manpower to produce high quality registration dossiers using our multidisciplinary team of regulatory affairs, scientific writing, and publishing, and to manage the submission process through to a successful conclusion.

 

In parallel, there is an opportunity take advantage of Early Patient Access programs particularly in France where a combination of patient exposure (under the nominative or cohort Temporary Authorisation for Use (ATU) process) and reimbursement is possible ahead of the formal Marketing Authorisation Application (MAA) approval. This can enable clients to reach the market many months in advance of receiving the MAA.

As every project and client situation is unique we provide a tailored package of services to meet the specific needs of the application

The time to engage with us

As there are a series of steps required prior to the point of even considering a new application in the US or EU it is important to be fully aware of the risks and mitigations associated with the submission process. It is also important to engage with BlueReg as soon as the interest in an Early Access Programme (EAP) is raised. The process of developing a dossier, the assessment process itself, and the orchestration of the EAP in conjunction with the full MAA must be well planned in order that the maximum value can be achieved. There are certain conditions associated with the programme that can make or break the opportunity for success.

 

Regulatory submission planning is a team effort with multiple inputs and stakeholders. It is preferable to develop regulatory submission strategy early and implement a tactical action plan to ensure that deliverables are met according to expectations. Early investment in time pays dividends in the overall time point as ensures all stakeholders are driving towards the same goals with the same set of assumptions. Flexibility in resource and budget allocation models means that the support provided to client projects can be tailored – we do not operate a ‘one size fits all’ approach. We recognise that there will be peaks and troughs in workload and this can be reflected in the contact time with the client organisation during period of agency dossier assessment or when waiting for clinical trial readouts.

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Registration and Early Access to Market component services

Clients rely on our regulatory intelligence as well as the experience and expertise of our consultants for the success of their project. We can provide you with an end-to-end project plan to guide you from registration strategy through to authorisation and beyond. Some of the services we offer include:

  • Early Access Programs, including ATU application (to the National Agency for the Safety of Medicines and Health Products (ANSM)) and acting as Exploitant
  • Global registration strategy in major territories or export countries
  • Registration, centralised procedure (CP), decentralised procedure (DCP), mutual recognition procedure (MRP) and national submissions in Europe
  • Preparation and management of New Drug Application (NDA)/ Biologics License Application (BLA)/ Abbreviated New Drug Application (ANDA) in the US
  • electronic Common Technical Document (eCTD) publishing

  • International and export country registration
  • Compilation of Module 1 documents including development of Summary of Product Characteristics (SmPC), risk management plan and environmental risk assessment
  • National requirements for local submission, including advice on the redaction of full dossiers for international registrations
  • Preparation of labelling includingSmPC, Patient Information Leaflets (PIL), Package Inserts (PI) and Structured Product Labelling (SPL)
  • Product name applications
  • Full integration of our consultants within global project teams
  • Advice on registration strategy: legal basis and selection of registration route.

“Thank you to you and the entire BlueReg team for all your help preparing and completing this submission!  Thanks for helping us reach this critical milestone.”

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

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

Specific Services for the United States

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

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

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

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

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

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

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.

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. 


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