Registration
& Early Access to Market
With clinical trials nearing an end, non-clinical study reports finalised and the Quality and CMC dossier planning and executing the new registration application is critical for the timely success of the product development programme.
As every project and client situation is unique we provide a tailored package of services to meet the specific needs of the application.
In parallel, there is an opportunity take advantage of Early Patient Access particularly in France where a combination of patient exposure (under the nominative or cohort ATU process) and reimbursement is possible ahead of the formal MAA approval. This can enable clients to reach the market many months in advance of receiving the MAA.
“Thank you to the entire BlueReg team for all your help preparing and completing this submission and helping us reach this critical milestone!”
Registration and the time to engage with BlueReg
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 us as soon as the interest in an Early Access Programme is raised. The process of developing a dossier, the assessment process itself, and the orchestration of the EAP in conjunction with the full MAA has to 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 ‘size fits all’ approach. We recognise that there will be peaks and troughs on 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.
“Thank you very much to you for your always efficient work and your close monitoring of regulatory developments. Totally shared pleasure!”
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 ANSM)
- Acting as Exploitant
- Global registration strategy in major ICH territories or export countries
- Registration, centralised (CP), decentralised (DCP), mutual recognition (MRP) and national submissions in Europe
- Preparation and management of NDA/BLA/ANDA in US
- eCTD, publishing
- International and export country registration anywhere in the World
- Provision of all Module 1 documents including development of SmPC, risk management plan, environmental risk assessment
- National requirements for local submission, including advice on the redaction of full dossiers for international registrations
- Preparation of labelling ; Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), Package Inserts (PI), Structured Product Labelling (SPL)
- Product name applications
- Full integration of our consultants within global project teams for new indications, line extensions
- Advice on registration strategy: legal basis and selection of registration route.
Associated services
Program Management
Looking for peace of mind with outsourcing your regulatory projects and/or activities? BlueReg provides a tailored service with a continual monitoring and partnering with our experienced project managers to ensure a high quality of deliverables as per KPIs and metrics agreed at project initiation.
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
SME representation
Looking for support of small to medium enterprise (SME) status in the European Union? BlueReg coordinates SME client status dossier preparation and submission through its experienced project management team. BlueReg can also optimise the application content to expedite the approval by EMA.
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
BlueReg provide expertise in registration strategy in the US or in Europe, provide manpower to produce high quality registration dossiers using our multidisciplinary team of regulatory affairs, scientific writing, and publishing, and manage submission process through to a satisfactory conclusion
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
Early & Expanded Access Programs in France
Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France .
Associated services
Exploitant Services
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).
Case study
French Early Access Program management for a US pharmaceutical company
An American pharmaceutical company starting to build its European affiliates entrusted PharmaBlue with the responsibility of submitting, obtaining, and implementing...
Learn more