The challenges faced by BlueReg clients largely result from not having the expertise in house, the lack of infrastructure or support at their disposal, or being unfamiliar with the regulatory environment in the target market.
BlueReg works with clients who are passionate about their research and development of medicinal products and are committed to the unmet medical need that they are trying to solve.
BlueReg is engaged with clients throughout the product development and the registration process. This continuity of relationship builds trust and a deep understanding of the product and future strategy with the rollout to market. Clients also approach BlueReg to help with launch activity and to plan for future management of their product across the World. The ability to scale activity in one or more markets is highly important to reaching Healthcare Professionals (HCP) and patients alike in a timely fashion.
Clients approach BlueReg, often with a first or second therapeutic asset, looking for regulatory support and guidance. The expectation is to expedite speed to market, maximise or at least retain the asset value by not building the regulatory support infrastructure until it is needed at commercialisation or obtaining a return on investment (ROI) as quickly as possible.
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 on workload and this can be reflected in the contact time with the client organisation during the period of agency dossier assessment or when waiting for clinical trial readouts.