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Coordination and regulatory support - BlueReg Group

Coordination and regulatory support across Europe and the rest of the world

BlueReg Group Coordination and regulatory support across Europe and the rest of the world

Coordination and regulatory support
across Europe and the rest of the world

This service is utilized by small start-up companies or companies that have not yet had a product reach the EU or US market. They generally have no in-country regulatory resource. This service may also be of interest to medium sized companies who do not have presence in all countries in the world.

 

This service can be used during the entire geographical rollout registration process and geographical rollout, through to launch and marketing of the product once it is approved.

 

We can guide you through:

  • Any country to country requirements for local regulatory strategy & registrations,
  • Post-approval submissions
  • Launch preparation
  • Promotional copy review & regulatory validation
  • Healthcare compliance
  • PV
  • Quality
  • Supply chain & labelling review
  • Pricing and & reimbursement

In addition  to our affiliates in France and the UK, we have a network of partners around the world. All our partners are fully qualified and have significant experience in their area and market.

 

With BlueReg, you only need to deal with one contract, one point of contact and one invoice. You will receive consistent, consolidated feedback through your dedicated Project Manager.

 

We will discuss your needs and co-ordinate the collection of information and provision of services with our affiliates & partners worldwide.

European Union Project

Promotional & Advertising material review (drugs and medical devices)