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)
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).
“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.”
FDA GUIDANCE – COVID-19
BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...
News - 24 April 2020
EMA GUIDANCE – COVID-19
Given the support given to our clients in interactions with health authorities all around the...
News - 23 April 2020