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)
  • Paediatric 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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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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RAPS Regulatory Convergence in Philadelphia

BlueReg team will attend the RAPS Regulatory Convergence in Philadelphia, from September 21st to 24th....

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