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

 

 

 

BlueReg regulatory consultancy in Registration

 

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.

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.
Chemistry-Manufacturing-and-Controls

“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.”