BlueReg has developed a unique methodology to support your projects when complete or partial outsourcing is required along with appropriate project management tools.

That can concern:

• European & US registrations
• Worldwide geographical rollout (OPREC)
• Lifecycle management, launch and Early access programs (OPPARS)
• Promotional material review (OPPROS)
• Publishing (OPPUS)

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).