In many situations we are engaged with clients throughout product development and the registration process. This continuity of relationship builds a deep understanding of the product and future strategy with the rollout to market. But this is not always the case and clients approach us during first registration to help with launch activity and to plan for future management of their product across the World.
The challenges faced by our clients largely result from not having the expertise in house but often the ability to manage high peaks and troughs coming from commercial launch decisions. The ability to scale activity in one or markets is highly important to reaching Healthcare Professionals (HCP) and patients alike in a timely fashion.
Once the product is approved consideration must be given to managing the product in an organised and cost-effective fashion. We provide management consultancy to guide clients in the design of a future operating model to support a commercial operation and, if required, we can support an outsourcing service accordingly. We are able to act as Exploitant in France for commercial products or advise clients in how to setup themselves.
Commercialisation planning and execution is paramount to a timely launch of the product in the concerned market. This group of activities requires a team of specialists that follow a detailed plan and the regulatory roadmap. There is a great deal of resource required in a short space of time and clients look to BlueReg to ramp up capability and capacity in quick time. Developing a team approach involves determining a clear set of roles and responsibilities.
To execute a timely product launch the management of the final registration package is key so that there is no delay in the administrative elements such as provision of the approved labelling, and translated documentation in order, and confirmation of any post approval commitments.
BlueReg is well known for Advertising and Promotional copy review during the launch phase. We provide experts in their field, well used to managing local codes of practice and manging activity in local language and in client systems such as Veeva®, Trackwise® and so on. We manage and coordinate activity to ensure a consistent approach across markets so that a practical level of feedback is provided and in a consistent manner.
We can provide you with an end-to-end project plan to guide you from the development of your product right through to authorisation and beyond. Some of the services we offer include:
BlueReg consultants can help navigate International regulations and provide support and advice for all your project requirements
Clients rely on BlueReg’s regulatory intelligence as well as the experience and expertise of our consultants and partner network for the success of their projects. BlueReg can provide an end-to-end project plan to guide you through the regulatory preparation of the commercial product launch.
The dedicated BlueReg lifecycle management product supply team are experts in navigating post approval activities and supporting client partners to successfully manage all post approval activities.
BlueReg consultants can provide pricing and reimbursement insight and support you prior to the launch of your products in France. BlueReg has a team of Market Access experts dedicated to supporting your company through the full pricing and reimbursement process (medicinal products and medical devices).
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.
BlueReg experienced consultants can provide full support in designing and implementing a quality system that meets regulatory expectations in France.
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.
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).
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