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, from geographical rollout through to launch and marketing of the product following approval.

earth

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 specialty 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.

Our experts

Associated News

FDA GUIDANCE – COVID-19

BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...

Learn more

How antibody testing can help us fight COVID-19 ?

There is a high demand around the need for antibody testing and the media frenzy...

Learn more

BlueReg continues to expand in the US opening its second North American office in Boston

Cambridge, Massachusetts, USA, December 13 2019, BlueReg, the consulting organization for life sciences companies, is...

Learn more