BlueReg has developed a unique methodology to support your projects when complete or partial outsourcing is required along with appropriate project management tools.
Outsourcing engagements typically concern the following:
For any of these activities, a BlueReg Project Manager will be assigned to your project as key contact point person along with a dedicated team of highly experience BlueReg consultants specialised in regulatory affairs, scientific writing or publishing.
A tailored service with a continual monitoring will be set up by the Project manager to ensure a high quality of deliverables and respect of timelines as per KPIs and metrics agreed at the project initiation. Long relationship is key for such a project and BlueReg focus will be to maintain smooth transition between all steps of the project and ensure that roles & responsibilities are clear for all stakeholders (RACI).
In recent years, the industry has seen a significant increase in outsourcing activity. The decision to outsource is made often in the interests of lowering costs, redirecting or conserving energy directed at the competencies of a particular business, or to make more efficient use of resources. Its aim is to help companies achieve their business objectives through operational excellence.
With something of an unpredictable starting point, normally based around an event or acute need, clients value BlueReg’s experience and established platforms for key elements of support. There is comfort from knowing that this isn’t the first time that BlueReg will have carried out such outsourced services. That said, it is also of value to our clients that we do not consider a ‘one size fits all’ approach. Our team has experience from a wide variety of professional service environments and this enables the opportunity to really understand and construct a pragmatic and working model that works for that given situation.
Of course the time to discuss such outsourcing services is as soon as possible particularly as, sometimes, detailed planning and preparation time is required to ensure future success. However, we aim to support our clients in whatever circumstances are presented and develop a trusting collaboration.
BlueReg delivers its services based on a platform approach. BlueReg provides comprehensive regulatory affairs services, in global regulations and intelligence, across all regions of the world, supported by the expertise of our consultants and our international qualified partners.
BlueReg support companies in registration roll out in ICH and non-ICH regions by providing advice and regulatory support on the various steps of regulatory plans.
This includes:
