Specific Services for the
United States

Our market specific services for the United States

The Food and Drug Administration (FDA) is responsible for protecting and promoting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices.

Our consultants can help navigate FDA regulations and provide support and advice for all your project requirements. Specific services provided by our team include:

  • Pre-Market Notification (510(k))
  • Pre-Market Approval (PMA)
  • Investigational New Drug application (IND)
  • New Drug Application (NDAs)
  • Biologics License Application (BLAs)
  • Pediatric Study Plans / Orphan Drug Designation
  • Submission to the FDA (Electronic Submission Gateway)

Our experts

Associated News

FDA GUIDANCE – COVID-19

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

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How antibody testing can help us fight COVID-19 ?

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

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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...

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