Product Registration in the United States & Europe

Clients request 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 regulatory affairs, scientific writing, and publishing team, and to manage the submission process through to a successful conclusion.  As every project and client situation is unique we provide a tailored package of services to meet the specific needs of the application.

 

Major regions within the International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are often the priority for first registration and are the attractive starting points for the global dossier through optimised and harmonised requirements.

 

The vast majority of our clients that are looking for first registrations are looking for support in US and EU New Drug Application (NDA)/ Biologics License Application (BLA)/ Marketing Authorisation Application (MAA). Our teams provide a full service from authoring modules, preparing labelling, publishing and submitting directly to agencies.  As the BlueReg team manages these submissions for clients in both the US and EU in parallel it brings efficiencies in timelines and cost.

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Time to engage with BlueReg

There is a myriad of guidance documents published by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the submissions themselves so engaging with BlueReg at the earliest opportunity is vital to ensure there is a clear understanding of the regulatory pathway and up to date implementation of the dynamic registration requirements in the target territory.

 

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 itself and being organised around specific milestones along the way. Preparing and submitting the initial registration file is only the first step in the process.

 

 

 

In the US, many of the same regulations apply to NDAs and BLAs, including labelling and advertising rules, accelerated approval pathways, paediatric study requirements, and Prescription Drug User Fee Act (PDUFA) fees.  Our experts will provide input and support through close collaboration.

 

In addition, in the EU there are possible options to address patient need and provides for accelerated assessment, i.e. reduced timeframe for MAA review for medicines of major public health interest and in particular from the viewpoint of therapeutic innovation. Also conditional marketing authorisations can be granted on the basis of applications that may contain incomplete data.

 

The EU PRIME (PRIority MEdicines) facility is available to enhance support for the development of medicines that target unmet medical need. PRIME is a voluntary scheme requires a higher degree of interaction and dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.  Whilst PRIME is designed to promote accelerated assessment, it will also help companies make use of EMA other early access routes and additional advisory support within the qualifying criteria of the centralised procedure.

New product registration services

At BlueReg we share our client’s passion for bringing new products (pharmaceuticals, advanced therapies or medical devices) or therapeutic indications to the benefit of patients.  Our consultants have come from similar environments as our clients and have ‘walked in their shoes’.  As a result the working relationship during such projects is special and the real collaboration between consultants and client stakeholders blurs the lines of client / service provider.

 

Clients rely on our regulatory intelligence as well as the experience and expertise of our consultants for the success of their project. BlueReg 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:

 

  • Registration, centralised (CP), decentralised (DCP), mutual recognition (MRP) and national submissions in Europe
  • Preparation and management of NDA/BLA/ Abbreviated New Drug Application (ANDA in the US
  • electronic Common Technical Document (eCTD), publishing
  • 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 future redaction of full dossiers for international registrations
  • Preparation of labelling including SmPC, Patient Information Leaflets (PIL), Package Inserts (PI) andStructured Product Labelling (SPL)
  • Product name applications
  • Full integration of our consultants within global project
  • Advice on registration strategy: legal basis and selection of registration route.

 

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.