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

This service is utilised 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, from geographical rollout through to launch and marketing of the product following approval.

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BlueReg can guide you through:

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

In addition to our offices 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 technical speciality 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.

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